Roche Pegasys sBLA Filing For Hepatitis B Could Receive Priority Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Roche announced simultaneous U.S. and European submissions July 21; six-month review would set user fee date at mid-January. Roche is likely to highlight superiority to GlaxoSmithKline’s Epivir-HBV and efficacy in HBeAg-negative patients in promotions.
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Roche's Pegasys Gains Hepatitis B Indication
FDA clears peginterferon alfa-2a for treatment of HBeAg-positive and negative chronic hepatitis B patients; approval is based on two Phase III head-to-head trials with GlaxoSmithKline's Epivir-HBV. Roche is highlighting Pegasys' limited duration of treatment relative to other hepatitis B therapies.
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