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ZALBIN is a long-acting investigational treatment for chronic hepatitis C, and is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. ZALBIN has met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) in two pivotal Phase 3 clinical trials in chronic hepatitis C. The results of both Phase 3 trials demonstrate that, with half the injections, 900-mcg ZALBIN achieved efficacy comparable to peginterferon alfa-2a, with rates of serious and/or severe adverse events that were also comparable. We have submitted a Biologics License Application to the FDA for ZALBIN dosed every two weeks in the United States, and have received confirmation that our submission was accepted for filing with a PDUFA target date of October 4, 2010. Assuming licensure by the FDA and other regulatory agencies, HGS believes that ZALBIN could become an important treatment for chronic hepatitis C.
More Info about Zalbin
| Drug Type: | STD |
| Current FDA Status: | Unknown |
| Current Drug Phase: | NDA |
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