May 13, 2005 FDA Approves Pegasys for Chronic Hepatitis B
Drug News -- May 13, 2005
FDA Approves Pegasys as the First and Only Pegylated
Interferon for the Treatment of Chronic Hepatitis B
Pegasys-- Most Prescribed Hepatitis C Medication -- Now Approved
for 1.25 Million Americans with Chronic Hepatitis B
NUTLEY, N.J., May 13, 2005 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Pegasys (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 Pegasys PDR Information for additional information about Pegasys indication and safety.
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