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FDA Grants Priority Review to Pegasys with Copegus for HCV in HIV Patients
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This press release distributed by roche and emailed to you for your information.
- Signals Major Step Toward Satisfying Unmet Medical Need -
Nutley, NJ --October 6, 2004 -- The U.S. Food and Drug Administration (FDA) has granted a sixmonth Priority Review Status to the supplemental new biologics license application (sBLA) for Roche's combination therapy of Pegasys (peginterferon alfa-2a) in combination with Copegus (ribavirin, USP) for the treatment of chronic hepatitis C in patients co-infected with HIV. Roche submitted this file with the FDA in August 2004.
Pegasys, the most prescribed hepatitis C medication in the U.S., is approved for use alone and in combination with Copegus for the treatment of adults with chronic hepatitis C. Priority review designation was granted for the Pegasys and Copegus submission in co-infected patients because the indication would address an unmet medical need.
"There are currently no approved treatments for the approximately 300,000 people in the United States with HIV who are infected with hepatitis C," said Juan Carlos Lopez-Talavera, M.D., Ph.D., Senior Medical Director, Roche. "Roche invested in the research to pursue an indication for Pegasys combination therapy in co-infected patients because we recognized that the need is urgent.
Liver failure resulting from chronic hepatitis C is now one of the leading causes of death in people with HIV."
HCV and HIV are the two most prevalent blood-borne infections in the United States, and HCV/HIV co-infection is increasingly recognized as a growing public health problem.
According to the Centers for Disease Control, hepatitis C has become a major cause of death for people with HIV. Almost four million Americans are believed to have chronic hepatitis C.
The file submitted to the FDA includes results from APRICOT (AIDS Pegasys Ribavirin International Co-infection Trial), the largest study conducted to date evaluating chronic hepatitis C treatment in patients co-infected with HIV and HCV. APRICOT is one of the six Pegasys studies published in The New England Journal of Medicine. The results showed that 40 percent of patients treated with Pegasys and Copegus achieved a sustained virological response (SVR). SVR refers to a patient's continued undetectable hepatitis C virus levels in the blood 24 weeks after finishing a course of treatment.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the FDA in December 2002 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 included 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 available as a 200mg tablet, and is administered orally two times a day as a split dose. 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, patients with normal ALT levels, and patients who have failed to respond to previous therapy.
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