Hepatitis

Application filed to market Pegasys for hepatitis and AIDS coinfection

Published in Medical Letter on the CDC and FDA, October 3rd, 2004

Roche announced the submission of a supplemental new biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) to market Pegasys (peginterferon alfa-2a) in combination with Copegus (ribavirin, USP) for the treatment of chronic hepatitis C in patients coinfected with HIV.

The indication has been granted fast track status by the FDA, a designation designed to facilitate the development and expedite the review of drugs that address serious, unmet medical needs.

Pegasys is approved for use alone and in combination with Copegus for the treatment of chronic hepatitis C. Pegasys and Copegus are the first hepatitis C medications...

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Source: Medical Letter on the CDC and FDA (2004-10-03)

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