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FDA Approves Pegasys Monotherapy Today
reported by Jules Levin
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Today October 16, the FDA approved Pegasys, pegylated interferon Roche brand,
as monotherapy for treating Hepatitis C, and announced it tonite at 6:30pm.
The FDA is currently reviewing the Roche application for combination therapy
of Pegasys + ribavirin and approval for the combination is expected in
December. Ribavirin and Pegasys will be available to be purchased separately.
Pegasys will be available for purchase soon in the pharmacy. Roche announced
today a program making Pegasys available for free for 12 weeks to up to
15,000 individuals, and this program is described below. Doctors can call on
Monday 1-877-Pegasys to get information about this program and regarding
followup access to Pegasys after the 12-week program. The free drug will
available on a first come first served basis, so if you would like to acquire
drug through this program your doctor should call immediately. Roche
announced that starting Monday October 21 the Pegasys reimbursement
assistance program, Pegassist, will be up and running by Monday to assist
patients with coverage or access through Roche.
To read about the two Pegasys+ribavirin studies in HCV-monoinfected patients
and the results which will be reviewed by the FDA for approval of the
combination, here is the link to NATAP reports:
Pegasys + Ribavirin: 24 vs 48 weeks; 800 vs 1000/1200 ribavirin (April 2002)
www.natap.org/2002/easl/day1.htm
Pegasys + Ribavirin: study results published in New England Journal of
Medicine (Sept 2002)
http://www.natap.org/2002/september/092702_1.htm
Press Release From Roche
FDA Approves Pegasys (peginterferon alfa-2a)
For the Treatment of Hepatitis C
Roche sample program to provide first 12 weeks of Pegasys at no cost
for up to 15,000 patients
NUTLEY, N.J. (October 16, 2002) - Roche announced today that the U.S. Food
and Drug Administration (FDA) has approved Pegasys" (peginterferon alfa-2a)
for the treatment of adults with chronic hepatitis C who have compensated
liver disease and have not previously been treated with interferon alpha.
Patients in whom efficacy was demonstrated included patients with compensated
cirrhosis.
Pegasys is a pegylated interferon that remains active in the bloodstream
longer and at a more constant level than interferon alpha. Currently, 2.7
million Americans are chronically infected with hepatitis C.
"The approval of Pegasys is an important milestone for the hepatitis C
patients in the United States who are waiting for treatment," said George B.
Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc.
"Roche has supported Pegasys with the most extensive development program ever
undertaken for a hepatitis C treatment. The result is that patients and
physicians have an important new option for treatment."
Pegasys was granted approval based on the results of three pivotal Phase III
clinical trials that demonstrated it is an effective treatment for patients
with chronic hepatitis C, including cirrhotic patients with compensated liver
disease, versus treatment with Roferon-A® (interferon alfa-2a). Two of these
pivotal trials were published in The New England Journal of Medicine.
The sustained virological response rate in the Pegasys treated patients was
as high as 38 percent in the overall population versus 19 percent in the
interferon alfa-2a group. The sustained virological response in patients
with cirrhosis treated with Pegasys was as high as 30 percent versus 8
percent in the interferon alfa-2a group. Higher sustained virological
response results were also found in patients with genotype 1, on Pegasys
treatment (23 percent) versus interferon alfa-2a (6 percent), the most common
type in the U.S. and most difficult to treat. Sustained virological response
was defined as undetectable serum hepatitis C RNA levels post-treatment (on
or after study week 68). Clinical trials of Pegasys have shown that patients
can determine at 12 weeks if they are unlikely to attain a sustained
virological response with Pegasys. Pegasys investigator, Donald Jensen, MD,
director of Hepatology at Rush-Presbyterian-St. Luke's Medical Center,
Chicago said, "With Pegasys, we can determine at week 12 of therapy those
patients who are unlikely to achieve a sustained virological response to
treatment. This reduces the cost and burden of taking therapy for patients
who are unlikely to respond to therapy. This may help patients adhere to
therapy that can be difficult on them, particularly during the first few
months."
12-Week Sample Program for Up to 15,000 Patients
As part of Roche's commitment to treating patients with hepatitis C, Roche
will be providing physicians with samples of Pegasys for the first 12 weeks
of therapy. These samples will be provided at the request of a physician for
the first 15,000 patients who are started on Pegasys therapy prior to
December 31, 2002. Twelve weeks was selected because at that point
physicians can predict those patients who will not respond to Pegasys
therapy. Samples are available to all physicians.
Pegasys, available as a premixed solution, is expected to be in pharmacies
within two weeks. Pegasys is dosed at 180 ug as a subcutaneous injection
once a week for a recommended duration of 48 weeks.
Pegasys is supported by the most extensive development program ever
undertaken for a hepatitis C treatment. The FDA has granted Pegasys in
combination with Copegus® (Roche ribavirin) priority review status, and a
decision is expected by the end of 2002. The FDA grants priority review
status to products that, if approved, are expected to offer a significant
improvement over existing therapies in the safety or effectiveness of the
treatment, diagnosis or prevention of a serious or life-threatening disease.
About Pegasys
Pegasys has been studied in a variety of patient populations, including those
with the most difficult to treat form of the disease - patients with genotype
1 and with cirrhosis (scarring of the liver).
Pegasys is made when interferon alfa-2a undergoes the process of pegylation
in which one or more chains of polyethylene glycol, also known as PEG, are
attached to another molecule.
In Pegasys, a large, branched, mobile PEG is bound to the interferon alfa-2a
molecule and provides a selectively protective barrier. Pharmacokinetic
behavior of the end product depends on the length of the PEG and the nature
of the link between the PEG and the protein. The high molecular weight (40
kilodalton) branched PEG in Pegasys has been shown to provide sustained
pegylated interferon alfa-2a exposure at clinically effective levels over the
one-week dosing period. In contrast, interferons with smaller PEGs are
excreted more rapidly by the kidneys, requiring more frequent dosing,
according to earlier Roche studies, using smaller PEGs developed by the
company. Pegasys has been approved for use in 50 countries, including all
European Union countries.
Pegasys Adverse Events
Alpha interferons, including Pegasys, may cause or aggravate fatal or
life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs
or symptoms of these conditions should be withdrawn from therapy. In many,
but not all cases, these disorders resolve after stopping Pegasys therapy.
Pegasys is contraindicated in patients with hypersensitivity to Pegasys or
any of its components, autoimmune hepatitis, and decompensated hepatic
disease prior to or during treatment with Pegasys. Pegasys is also
contraindicated in neonates and infants because it contains benzyl alcohol.
Benzyl alcohol has been reported to be associated with an increased incidence
of neurological and other complications in neonates and infants which are
sometimes fatal.
The most common adverse events reported for Pegasys, observed in clinical
studies to date, were headache, fatigue, myalagia, pyrexia, rigors,
arthralgia, nausea, alopecia, injection-site reaction, neutropenia, insomnia,
depression, anorexia, and irritability.
Other serious adverse events include bone marrow toxicity, cardiovascular
disorders, hypersensitivity, endocrine disorders, pulmonary disorders,
colitis, pancreatitis, and ophthalmologic disorders.
The complete package insert is available upon request.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, the leading cause
of cirrhosis and liver cancer and the number one reason for liver transplants
in the U.S., is transmitted through body fluids, primarily blood or blood
products, and by sharing needles. In many patients, the mode of transmission
is unknown. Unfortunately, most people infected with hepatitis C are unaware
of it because it may take years for symptoms to develop. Hepatitis C
chronically infects an estimated 170 million people worldwide (three percent
of the world's
population), with as many as 180,000 new cases occurring each year. It is
estimated that less than 30 percent of all cases are diagnosed. If left
untreated, hepatitis C can be fatal for some patients.
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