FDA panel unanimously backs simeprevir

FDA's Antiviral Drugs Advisory Committee voted 19-0 in favor of approval of simeprevir from Johnson & Johnson (NYSE:JNJ) and Medivir AB (SSE:MVIR B) to treat HCV genotype 1 infection. While the vote was unanimous, the panel had varying opinions on how FDA should handle the reduced efficacy observed in Phase III trials in genotype 1a patients with the Q80K polymorphism. While some panel members recommended contraindicating genotype 1a patients with the Q80K polymorphism, others cited analyses presented by J&J that showed some Q80K positive patients do achieve sustained virologic responses (SVRs) when treated with simeprevir. Both the pharma and FDA are recommending genotype 1a patients be screened for the Q80K variant and that "alternative treatment options should be considered" for patients with the polymorphism (see BioCentury Extra, Oct. 22).

The specific PDUFA date for simeprevir is not disclosed, but Medivir said it expects a decision by the end of November. J&J's Janssen Research & Development LLC unit has ex-Nordic rights to develop and commercialize simeprevir from Medivir, which was off SEK5 to SEK89 on Thursday. The advisory committee recommendation came after market close in Sweden. Last month, Japan approved simeprevir to treat HCV genotype 1 infection. The second-generation HCV NS3/4A inhibitor is also under review in Europe. ...