|Human Genome Sciences decides to end development of hepatitis C drug|
|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.
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.