Human Genome Sciences decides to end development of hepatitis C drug Print E-mail
By Staff and Wire Reports   
Tuesday, 05 October 2010 08:48

Human Genome Sciences Inc. (NASDAQ: HGSI) on Tuesday announced its decision to end the development of Zalbin-The hepatitis C drug it was co-developing with Novartis. The decision comes in the wake of the FDA requesting more details before granting approval.

The company said today that it has received a ‘Complete Response Letter’ (CRL) from FDA, which is typically a request for further information on drug application. In June this year, the company had conceded that the drug is unlikely to get a FDA approval at its present dosage. The FDA had voiced safety concerns at that time about the proposed twice monthly 900 microgram dosage. The company had received a ‘Discipline Review Letter’-a standard method of communication sent by FDA indicating deficiencies of an application.

Novartis AG, Human Genome’s partner - had withdrawn an application in April for the drug, known as ‘Joulferon’ in Europe citing regulatory issues. The company was concerned that regulators in Europe will request key data.

The move was prompted by feedback from U.S. and European regulators as well as data from a Phase II study, Novartis said. And Novartis stopped developing Mycograb, generically efungumab, an anti-fungal it had targeted as an add-on treatment for invasive candidiasis, also known as yeast infection.




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