Biopharmaceutical company Human Genome Sciences Inc. (HGSI) said Monday, that the U.S. Food and Drug Administration, in a preliminary written feedback, has expressed concerns regarding the company's application to market 900-mcg ZALBIN dosed every two weeks, for the treatment of chronic hepatitis C.
ZALBIN, known as JOULFERON in Europe, is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology.
The company said the U.S. health regulator has expressed concerns regarding the risk benefit assessment of 900-mcg ZALBIN dosed every two weeks. The FDA feedback was provided through a Discipline Review letter to convey early thoughts on possible deficiencies of an application.
The company submitted a Biologics License Application to the FDA for ZALBIN for the treatment of chronic hepatitis C last November. Following the regulatory agency's preliminary written feedback review of bimonthly ZALBIN dose, Human Genome has concluded that licensure of this dosing regimen is unlikely.
Human Genome and Novartis jointly develop ZALBIN under a deal signed in 2006. They 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.
In April HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency.
HGSI closed Friday's regular trading session at $26.51.
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