Once Weekly Diabetes Drug Wins FDA Approval on Third Try
http://blogs.nature.com27 Jan 2012 | 16:28 EST | Posted by Rebecca Hersher |
Third time's the charm for Amylin Pharmaceuticals. After two failed attempts in as many years, the San Diego-based drugmaker finally won approval today for its once-weekly diabetes medication Bydureon (exenatide).
Bydureon is a reformulation of the company's own twice-daily injectable Byetta. Like Byetta and Novo Nordisk's bestselling daily injectable Victoza (liraglutide), Bydureon mimics the gut hormone GLP-1 (glucagon-like peptide-1) to lower blood sugar levels. But Bydureon takes advantage of a controlled release technology developed by Alkermes, based in Cambridge, Massachusetts, to offer long-lasting diabetes care with fewer stabs of the needle and with an additional benefit over Byetta: weight loss.
That's no small perk, notes Daniel Drucker, a diabetes researcher at Mount Sinai Hospital's Samuel Lunenfeld Research Institute in Toronto. "This is a substantial advance for hundreds of thousands of patients who don't like multiple injections and who are concerned struggle with weight gain on insulin therapy," says Drucker, who led a phase 3 trial for Bydureon.
How many people currently taking daily injectables will decide to switch over to Bydureon is still unknown, but forecasts were not helped by a clinical trial reported last year showing that Bydureon was not as effective as the daily injectable Victoza at controlling blood glucose. Amylin hopes that benefits for weight and compliance will give Bydureon an edge where efficacy does not.
Bydureon may not have the weekly injectable field to itself for long, though. Indiana's Eli Lilly and Britain's GlaxoSmithKline both have long-acting GLP-1 analogs in phase 3 trials and Denmark's Novo has a pair of weekly injectables in its pipeline, too.
Extended-Release Exenatide Outperforms Twice-Daily Version
A clinical trial showed that after 24 weeks of treatment, patients taking extended-release exenatide lowered their hemoglobin A1c by 1.6 percentage points from baseline compared with a 0.9-percentage point reduction for patients taking the twice-daily version, Amylin stated in a press release.
The most common adverse effects that emerged in clinical trials were nausea (which usually decreased over time), hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation, and asthenia.
Amylin stated that its newly approved drug will be available in pharmacies next month.
Amylin executives say the convenience of the drug's weekly regimen should give it a competitive advantage in the marketplace. However, last year Amylin reported disappointing results for Bydureon against Novo Nordisk's Victoza, a once-daily injection approved last January. On average, Bydureon reduced blood sugar levels in diabetics less than Victoza, which uses a different mechanism of action.
Bydureon is already on the market in Europe after being approved there in 2010, but was delayed in the US while the FDA asked for additional information on how the extended-release formulation affected the heart.
It uses the same active ingredient as Amylin's twice-daily Byetta injection, which has been on the market since 2005, but uses a long-acting formulation developed by partner Alkermes.
Class of once-weekly diabetes drugs poised for approval
Nature Medicine Published online 06 December 2011
The announcement last month that drugmakers Amylin Pharmaceuticals and Eli Lilly were parting ways is only the latest twist in their more than two-year quest for regulatory approval of their once-weekly injectable diabetes medication, Bydureon. The companies first filed for approval with the US Food and Drug Administration (FDA) in May 2009, and in the intervening period they have had to deal with two complete response letters for manufacturing issues and potential heart problems. But with new trial data in the bank and Bydureon's European approval in June, things are looking up, and a decision is expected from the FDA by 28 January.
"I think that the FDA will very likely approve Bydureon," says senior biotechnology analyst Thomas Wei of the investment firm Jefferies in New York. "And a big part of the reason I think that this will be successful is that the efficacy looks very good."
Bydureon, a reformulation of the company's already approved twice-daily injectable, Byetta (exenatide), is just one of several diabetes drugs in the pipeline that mimic the gut hormone glucagon-like peptide-1 (GLP-1) to lower overall blood sugar by stimulating insulin and inhibiting the hormone glucagon. And GLP-1 mimics have an edge over other drugs that act further upstream: they not only lower blood sugar but also cause weight loss. In a phase 3, 456-person trial, people taking Bydureon lost 2.6 kilograms (5.7 pounds) on average over a 26-week span-significantly more than those on insulin alone, who had an average gain of 1.4 kilograms (Lancet 375, 2234-2243, 2010). (Similar effects have been reported for other GLP-1 analogs.) This extra benefit of the drug against obesity, which often accompanies type 2 diabetes, could help it beat out its competition.
"To finally have a diabetes drug that not only lowers your glucose but also tackles your weight at the same time-that's a real breakthrough for patients and doctors," says Daniel Drucker, a diabetes researcher at the Samuel Lunenfeld Research Institute at Mount Sinai Hospital in Toronto, who led phase 3 trials for Bydureon.
San Diego-based Amylin will receive custody of Bydureon in the split, but, even if approved, the drug faces competition down the road. British drug giant GlaxoSmithKline and New York-based Eli Lilly each have their own long-acting versions of GLP-1 analogs in phase 3 trials. Meanwhile, Denmark's Novo Nordisk has a pair of once-weekly GLP-1-like drugs in the works: one, currently in phase 2 testing, is a novel molecule called semaglutide, and the other is a reformulation of Victoza (liraglutide), the company's bestselling daily injectable diabetes drug, which is in phase 1 development.
Experts say that the clinical data published so far have not produced a runaway winner among these new drugs. "There aren't huge differences in efficacy or potency in regards to how they work," says Drucker. The driving factor may come down to how much weight people lose in comparative trials. The different GLP-1 analogs vary in size, so some of the drugs may be less able to cross the blood-brain barrier than others. "A question that all of us have is: how important is it for these drugs to access regions in the brain that control appetite and body weight?" Drucker says.
Another unknown is the long-term effect of each drug on morbidity and mortality- although Amylin and Novo Nordisk both have ongoing long-term trials which should produce results in 2016 if not before. But, until the long-term effects are known, it may not be reasonable to ask patients to pay more for these drugs, despite their convenience, says Nicole Pinelli, a clinical pharmacy specialist at Wayne State University in Detroit. "If there's nothing to say that these drugs reduce cardiovascular morbidity or mortality, it's hard to justify using them above and beyond the generic drugs that are currently on the market," she says.
FDA Approves BYDUREON™ -- The First and Only Once-Weekly Treatment for Type 2 Diabetes
Provides Glycemic Control in a Once-Weekly Dose
SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.
"With BYDUREON, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control."
The approval of BYDUREON (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with BYDUREON resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTA® (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.
"As the first and only once-weekly diabetes treatment, BYDUREON represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "BYDUREON builds upon the proven benefits of BYETTA, offering significant improvements in glycemic control in a single weekly dose."
In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly BYDUREON experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking BYETTA. A1C is a measure of average blood sugar over three months. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking BYDUREON and 3.0 pounds for patients taking BYETTA (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREON users (14 percent) than by BYETTA users (35 percent). Other common treatment-emergent adverse events in the BYDUREON group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.
BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease. More information will be available at www.BYDUREON.com.
BYDUREON is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.
Amylin's once-a-week diabetes injection wins FDA approval after 2 previous rejections
By Associated Press, Published: January 27
WASHINGTON - Amylin Pharmaceuticals won approval Friday for its long-delayed diabetes drug Bydureon, a next-generation treatment that requires fewer injections than the company's 7-year old diabetes medicine, Byetta.
Bydureon is a once-a-week version of Byetta, which is taken twice a day to control blood sugar. Amylin executives say the new drug's convenient regimen will give it a competitive advantage in the marketplace. However, after multiple delays it enters a crowded market, including one diabetes treatement in the same class that has shown superior results.
The Food and Drug Administration approval comes after two rejections in 2010, when the agency asked Amylin to conduct a new study of the drug's effects on the heart's rhythm. News of the costly delay sent company shares tumbling more than 50 percent and contributed to the eventual breakup of Amylin's long-standing partnership with Eli Lilly and Co. The companies ended their collaboration in November, with Amylin paying $250 million and agreeing to take over full responsibility for both Byetta and Bydureon.
Analysts generally expect Bydureon to generate $940 million in sales annually by 2016, though Deutsche Bank analyst Robyn Karnauskas says the drug must post $1.2 billion annually to turn a profit.
Karnauskas points out in a note to investors that Amylin currently has $2 billion in long-term debt and only $210 million in cash. She says Bydureon's approval should give the San Diego company greater flexibility to refinance its debt.
Bydureon is part of the broader GLP-1 class of drugs, which work by increasing the body's insulin production.
People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because they've become resistant to the hormone, which controls blood sugar levels. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications. Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels.
Diabetes affects more than 25 million people in the U.S., or roughly 8 percent of the population.
Amylin executives say the convenience of the Bydureon's weekly regimen should give it a competitive advantage, but Amylin reported disappointing results last year for it against Novo Nordisk's Victoza, a daily injection approved in January 2010. On average, Bydureon reduced blood sugar levels in diabetics less than Victoza, which uses a different mechanism of action.
A monthly series of Bydureon injections is expected to cost $323, compared with $291 for the older Byetta.
Bydureon was co-developed with Indianapolis-based Eli Lilly, which also helped co-market Byetta. Both drugs are scheduled to transfer to Amylin by the end of 2013. Alkermes, based in Waltham, Mass., created Bydureon's formulation technology, which gradually releases the drug over the course of a week.
Diabetes Drug Injected Weekly Wins F.D.A. Approval
By ANDREW POLLACK
NY Times Published: January 27, 2012
Amylin Pharmaceuticals won federal approval on Friday for its new, more convenient drug for Type 2 diabetes, ending years of setbacks.
The drug, Bydureon, is injected once a week. Its main competitor is expected to be Novo Nordisk's Victoza, a similar drug that is injected once a day.
Novo Nordisk, apparently girding for competition, has hired Paula Deen, the celebrity chef, to promote Victoza. Ms. Deen revealed earlier this month, to much criticism, that she has had Type 2 diabetes for three years, all the while promoting recipes laden with fat and sugar.
The Food and Drug Administration twice declined to approve Bydureon in 2010, with its most serious concern being that the drug might contribute to heart rhythm abnormalities.
A study by Amylin, which is based in San Diego and led by Daniel M. Bradbury, suggested this was not the case. Analysts expected approval, so Amylin's stock rose only modestly Friday, closing up 1.7 percent at $12.14.
Analysts expect annual sales of Bydureon to eventually exceed $1 billion. But they are less enthusiastic than they once were, in part because of safety concerns involving thyroid cancer and pancreatitis.
David Kliff, publisher of Diabetic Investor, an electronic newsletter following the diabetes industry, said a once-weekly self-injection could make Bydureon an alternative for many patients to multiple insulin injections or even to multiple pills every day.
The failure of people to consistently take their medicines is "one of the biggest obstacles to better patient outcomes," Mr. Kliff, who has Type 1 diabetes, wrote in a note to clients Friday. "Think for a moment how much easier their lives would be by taking a drug just once a week, a drug that offers solid glucose control, does not require glucose monitoring and comes with added benefit of weight loss."
Bydureon is a longer-lasting version of Amylin's existing drug Byetta, which is injected twice a day. Alkermes, which supplied the technology that slowly releases Bydureon inside the body, is entitled to royalties on sales of the drug.
Bydureon, Byetta and Victoza are drugs called GLP-1 receptor agonists, which mimic the effect of glucagonlike peptide- 1, a hormone that increases insulin production when blood sugar is high.
The main ingredient in both Bydureon and Byetta is exenatide, a hormone derived from the saliva of the Gila monster, a poisonous lizard found in the Southwestern United States and Mexico.
Despite the less frequent injections, Bydureon will not automatically be preferred over Victoza.
That is in part because there is some data from one of Amylin's own trials suggesting Bydureon is slightly less effective in controlling blood sugar than Victoza. Also, it is more cumbersome for a patient to prepare Bydureon for each injection and the needle used is larger than for Victoza.
Amylin said the wholesale price of Bydureon would be $323.44 for four doses, or about $4,200 a year. That is between the roughly $3,400 for the low dose of Victoza and $5,000 for the high dose, said Mark Schoenebaum, an analyst at the ISI Group.
The F.D.A. is requiring Amylin to conduct a clinical trial, which has begun, to assess whether Bydureon increases the risk of heart attacks and other cardiovascular problems. The same trial will also look at whether the drug increases the risk for thyroid cancer, pancreatitis and other health problems.
Amylin, founded in 1987, has never been profitable from drug sales and it still faces hurdles. It must pay Lilly $1.2 billion over time from sales of Bydureon.
Robyn Karnauskas, an analyst at Deutsche Bank, said Amylin might be a takeover candidate for a big company.
Amylin, Alkermes Win FDA Approval of Once-Weekly Diabetes Drug
xconomy.com 1/27.12 luke timmerman
[Updated: 3:47 pm] Amylin Pharmaceuticals and Alkermes have gone to the FDA twice before to seek approval of their new diabetes drug, and been turned back, but now the persistence has paid off. The FDA has cleared their once-weekly injectable diabetes drug for sale in the U.S.
San Diego-based Amylin (NASDAQ: AMLN) and Dublin- and Waltham, MA-based Alkermes (NASDAQ: ALKS) today won clearance to start selling exenatide once-weekly (Bydureon) in the U.S., according to a letter posted on the FDA website. The approval came after the agency held up the application twice before-first in March 2010, and again in October 2010, saying it needed further assurance that the drug doesn't cause an irregular heart rhythm known as QT prolongation. The companies expressed confidence back in July that the issue had been resolved, based on results of an additional clinical trial. The drug won approval in Europe back in June.
[Updated with added detail on Alkermes royalty] The long-awaited U.S. approval is vital to future of Amylin, as it started investing back in 2005 in a $500 million Ohio factory to mass-produce the new drug. Amylin's fortunes have become even more tied to Bydureon since November, when longtime partner Eli Lilly bowed out of a collaboration to co-market the drug. Alkermes, which provided technology that made the drug last long enough in the bloodstream to turn it into a once-weekly injection, will pick up an 8 percent royalty on sales of the first 40 million units sold in a single year, and a 5.5 percent royalty once sales exceed 40 million units in a single calendar year. While there is competition from Novo Nordisk's liraglutide (Victoza) as a once-daily injection for diabetes, and various other oral pills and injectable insulin, the new drug from Amylin and Alkermes is the first treatment that can be injected as little as once a week. Amylin has been marketing the original form of exenatide (Byetta) as a twice-daily injectable since 2005.
About 25 million people in the U.S. have the disease, and numbers are growing fast as the nation's obesity rate continues to surge. The new Amylin drug could generate $1.25 billion in peak U.S. sales in 2018, said Cory Kasimov, an analyst with JP Morgan, in a note to clients on Nov. 11.
Amylin, Alkermes Once-Weekly Diabetes Drug Passes Heart Trial Demanded by FDA
Luke Timmerman 7/7/11
The diabetes drug that people are counting on at Amylin Pharmaceuticals, Eli Lilly, and Alkermes has passed a crucial test that the FDA demanded almost 10 months ago.
San Diego-based Amylin (NASDAQ: AMLN), along with its partners, said today that exenatide once-weekly (Bydureon) didn't appear to cause an irregular heart rhythm, known as QT prolongation, when it was studied in healthy individuals at both normal, and higher-than-normal doses. The study compared 75 people who were randomly assigned to get the new drug, or a placebo. Full study details weren't released in today's statement, but the companies said they plan to present the data at a future medical meeting, and submit the results for publication.
Investors and researchers are watching this study carefully because this drug seeks to replace a twice-daily injection with a once-weekly shot-raising the potential of a more convenient medicine for patients, and a steadier way to control blood sugar in people's daily lives. Amylin shares jumped 10 percent in after-hours trading after the announcement.
"The findings of this thorough QT study are clear. Exenatide did not lead to QT prolongation, even at very high concentrations in the blood," Christian Weyer, Amylin's senior vice president of R&D, said in a statement. "This study was designed in accordance with existing guidelines and in consultation with the FDA. We are confident in these results and will continue to work toward making Bydureon available to patients in the U.S. as soon as possible."
The FDA delayed the original application for approval of Bydureon last October, when it asked the companies for more data on the drug's effect on QT prolongation. The new data will be packaged together and shipped off to the FDA for review sometime before the end of September, the companies said. Amylin has the most at stake in the FDA's decision, since it only has two other approved products and the new drug is supposed to be its major profit driver for the future. But Waltham, MA-based Alkermes (NASDAQ: ALKS), the company with technology that makes the diabetes drug last long enough in the blood to enable once-weekly injections, also has a lot at stake. Alkermes stands to collect an 8 percent royalty on worldwide sales of the drug, without having to pay expenses for marketing or manufacturing.
The market clearly has potential to be lucrative for all the companies. Demand for new diabetes treatments is surging as an estimated 25 million people in the U.S. suffer from the disease, and incidence is expected to climb for years as more people develop complications from obesity. Jefferies & Co. analyst Thomas Wei forecasted, in a June 27 note to clients, that the drug has potential to generate U.S. sales of about $2.38 billion in 2016. The product was cleared for sale in Europe by regulators there last month.
Exenatide tQT Study Showed No Prolongation of QT Interval
Results to be Included in BYDUREON™ New Drug Application Resubmission in the Third Quarter of 2011
SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Jul 07, 2011 (BUSINESS WIRE) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the U.S. Food and Drug Administration (FDA) in support of the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. Using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint, demonstrating that exenatide at and above therapeutic levels did not prolong the corrected QT (QTc) interval in healthy individuals. Further, the study found no relationship between QTc interval and plasma exenatide concentrations.
The QT interval represents the amount of time the heart's electrical system takes to repolarize, or recharge, after each beat.1 As prolongation of the QT interval may increase the risk for cardiac arrhythmias, the FDA requires a tQT study for most new drugs in development. A tQT study is a specialized clinical trial designed to assess whether an investigational medication has the potential to prolong the QT interval.
"The findings of this tQT study are clear. Exenatide did not lead to QT prolongation, even at very high concentrations in the blood," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "This study was designed in accordance with existing guidelines and in consultation with the FDA. We are confident in these results and will continue to work toward making BYDUREON available to patients in the U.S. as soon as possible."
In its October 2010 complete response letter, the FDA requested a tQT study with exposures of exenatide at higher than typical therapeutic levels of BYDUREON, such as those that might be achieved in patients with impaired renal function. The companies plan to submit results of the tQT study to the FDA in the third quarter of 2011 as part of their reply to the complete response letter for the BYDUREON NDA.
This randomized double-blind study, designed in accordance with the FDA's published guidance on clinical evaluation of QT/QTc interval (ICH E14), compared the effects of exenatide at or above therapeutic concentrations to placebo on the QT interval in approximately 75 healthy volunteers. The primary endpoint was to determine whether exenatide administered at therapeutic and supratherapeutic concentrations differed from placebo in the mean change in the QTc interval (defined as the upper bound of the 95% confidence interval for placebo-corrected, baseline subtracted QTc being <10 milliseconds). All heart rate correction methodologies that satisfied the pre-specified selection criteria, including QTcP, QTcF and QTcI, met the primary endpoint. Moxifloxacin, an antibiotic known to prolong the QT interval, was used as a positive control. The companies plan to present the full data set at a major medical meeting and submit the data for publication.
BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON received marketing authorization in the European Union in June 2011.
Diabetes affects nearly 36 million people in the U.S. and an estimated 347 million adults worldwide.2 Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs more than $174 billion per year in direct and indirect medical expenses.3
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.4 In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.5 Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.6,7
About BYETTA® (exenatide) injection
BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not currently recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. See important safety information below. Additional information about BYETTA is available at http://www.BYETTA.com.
Important Safety Information for BYETTA® (exenatide) injection
Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Consider alternative therapy if this occurs. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.
These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For additional important safety information about BYETTA, please see the full Prescribing Information (www.byetta.com/pi) and Medication Guide (www.byetta.com/mg).
About Amylin, Lilly and Alkermes
Amylin and Lilly partnered to develop and market BYDUREON, which is based on proprietary technology for long-acting medications developed by Alkermes, Inc. BYDUREON is approved in the EU and is under regulatory review in the U.S.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego and has a commercial manufacturing facility in Ohio.
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Mass., Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.
1 Long QT Syndrome. Heart Rhythm Society. Available at: http://www.hrsonline.org/PatientInfo/HeartRhythmDisorders/IDisorders/index.cfm. Accessed July 7, 2011.
2 Danaei G, et al. National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. Lancet. 2011;DOI:10.1016/S0140-6736(11)60679-X.
3 Direct and Indirect Costs of Diabetes in the United States. American Diabetes Association. Available at: http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html. Accessed July 7, 2011.
4 Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.
5 Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.
6 Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 Suppl 1;S61-78.
7 Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
SOURCE: Alkermes, Inc.