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FDA Approves Pegasys(R) as the First and Only Pegylated Interferon for the Treatment of Chronic Hepatitis B
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NUTLEY, N.J., May 13 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Pegasys(R) (peginterferon alfa-2a), the most prescribed hepatitis C medication in the United States, for the treatment of chronic hepatitis B (CHB). Pegasys is the first and only pegylated interferon approved for the treatment of chronic hepatitis B, including both variations of the virus - HBeAg-positive and HBeAg-negative chronic hepatitis B.
"Chronic hepatitis B infection is a serious disease that causes more than 5,000 deaths in the United States each year," said Salvatore Badalamenti, M.D., Medical Director, Roche. "Pegasys now offers hepatitis B patients a treatment option that is taken for a fixed duration of 48 weeks with the goal of providing a lasting response after treatment is completed."
The Centers for Disease Control estimates that 1.25 million people in the United States are chronically infected with hepatitis B. Chronic hepatitis B can lead to cirrhosis, hepatocellular carcinoma and death.
"This approval provides another important option for the treatment of hepatitis B," said Frederick G. Thompson, President and CEO of The American Liver Foundation. "We commend Roche for its extensive research and commitment to treating people with chronic liver diseases."
Pegasys was approved in 2002 by the FDA for use alone and in combination with Copegus(R) (ribavirin, USP) for the treatment of adults with chronic hepatitis C. In February 2005, Pegasys became the first and only FDA-approved therapy alone and in combination with Copegus for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV whose HIV is clinically stable.
Pegasys has a dual mode of action; it slows replication of the hepatitis B virus and boosts the immune system.
Pivotal Studies
The two large-scale multinational phase III trials, in more than 1,500 patients with both the HBeAg-positive and HBeAg-negative variations of chronic hepatitis B, demonstrated that 24 weeks after a defined 48 week period of therapy, more patients achieved a sustained response with Pegasys than with lamivudine. These studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.
Specifically, hepatitis B patients treated with Pegasys had higher rates of:
* HBV seroconversion in HBeAg positive patients (32% Pegasys vs. 19% lamivudine)
* HBV DNA response (32% Pegasys vs. 22% lamivudine in HBeAg positive patients and 43% Pegasys vs. 29% lamivudine in HBeAg negative patients)
* ALT normalization in HBeAg negative patients (59% Pegasys vs. 44% lamivudine)
Conclusions regarding comparative efficacy of Pegasys and lamivudine treatment based upon the end of follow-up results are limited by the different mechanisms of action of the two compounds. Most treatment effects of lamivudine are unlikely to persist 24 weeks after therapy is withdrawn.
Recent results from a long-term follow up study presented at the annual meeting of the European Association for the Study of the Liver (EASL, April 13-17) indicate that patients with HBeAg-negative chronic hepatitis B who responded to treatment with Pegasys maintained the benefit for at least a year after treatment.
The phase III study results in HBeAg-negative chronic hepatitis B were published in September 2004 in the New England Journal of Medicine. The results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 annual meeting of EASL. Lead investigators of both studies stated that the results of the trials warrant Pegasys becoming a first-line treatment for HBeAg-positive and HBeAg-negative chronic hepatitis B.
Roche was granted approval by the EU Commission in late February 2005 to market Pegasys for the treatment of chronic hepatitis B. Pegasys is the only pegylated interferon with this indication in the EU.
About Chronic Hepatitis B
In the U.S., the most common modes of transmission of the hepatitis B virus are through sexual and blood-to-blood contact, although the disease can also be transmitted from pregnant women to their infants.
The number of new infections in the U.S. has decreased in recent years, in part due to the introduction of the hepatitis B vaccine in 1982. Almost all (90-95 percent) adults who contract hepatitis B clear the virus from their systems within a few months and develop immunity. The remainder of the infections become chronic, which is when the virus stays in the blood, infecting liver cells and possibly damaging them.
About Pegasys for Hepatitis C
Pegasys, a pegylated alpha interferon, and Copegus are indicated for use in combination 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 include patients with compensated liver disease and histological evidence of cirrhosis.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is administered orally at doses of 800-1200 mg daily.
Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co- infected with HIV and HCV, African
Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
Please see attached additional information about Pegasys indication and safety.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs
roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com and U.S.: http://www.roche.us).
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).
Pegasys is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation
Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), 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. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information). Use with Ribavirin. Ribavirin, including COPEGUSR, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed.
Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. Pegasys dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of Pegasys dose or are accompanied by increased bilirubin or evidence of hepatitic decompensation, Pegasys should be immediately discontinued.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials (N=451) were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%) weight decrease (16%) and mood alteration (9%). The adverse event profile of hepatitis B patients treated with Pegasys was generally similar to that shown for hepatitis C patients treated with Pegasys monotherapy except for exacerbations of hepatitis.
Serious adverse events included neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including thrombotic thrombocytopenic purpura, psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
SOURCE Roche
05/13/2005 19:05 ET
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