Human Genome Sciences Inc. (HGSI) announced the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for ZALBIN for the treatment of chronic hepatitis C.
The company said the BLA submission includes the results of 2 pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every 2 weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a dosed once each week.
The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naïve patients with chronic hepatitis C, the company added.
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