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news.The US Food and Drug Administration (FDA) has issued complete response letter (CRL) to Human Genome Sciences' (HGS) biologics license application (BLA) of 900mcg Zalbin (albinterferon alfa-2b, known in Europe as Joulferon), dosed every two weeks for the treatment of chronic hepatitis C.
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Following FDA’s complete response letter, HGS and Novartis have jointly decided to terminate the development of Zalbin.
Zalbin is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology.
Earlier in 2006, HGS and Novartis had entered into a co-development and commercialisation agreement to co-commercialise albinterferon alfa-2b in the US under the brand name Zalbin.