Human Genome Sciences receives FDA feedback for ZALBIN BLA

Jun 14 2010

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.

The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle for review disciplines (e.g., clinical) to convey early thoughts on possible deficiencies of an application. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency.

ZALBIN (JOULFERON) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. HGS and Novartis are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.