Human Genome Sciences sees little hope of FDA approval for hep C drug Zalbin in bi-monthly regimen

Based on preliminary written feedback from the US Food and Drug Administration regarding Human Genome Sciences' Biologics License Application seeking to market 900-mcg Zalbin (albinterferon alfa-2b, known in Europe as Jouleferon), the company has said it sees little hope that the drug will be licensed for the treatment of chronic hepatitis C every two weeks.

Via the standard method of reviews, a Discipline Review letter, the 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.

Novartis already pulled MAA for Jouleferon

Earlier this year, HGS announced that its Switzerland-based partner Novartis withdrew its Marketing Authorization Application for Jouleferon from the European Medicines Agency (EMEA; The Pharma Letter April 20). The Novartis decision was based on feedback from European regulatory authorities in preliminary response to the EMEA application, indicating that additional new data would be requested which could not reasonably be generated within the timeframe allowed in the European Centralized Procedure.