Johnson & Johnson and partner Medivir have been boosted by the news that advisors to the US Food and Drug Administration have unanimously recommended approval of their hepatitis C therapy simeprevir.
The agency’s Antiviral Drugs Advisory Committee voted 19-0 in favour of simeprevir in combination with pegylated interferon and ribavirin for the treatment of hepatitis C genotype 1 infections. The recommendation for approval is based on analyses of data from clinical trials in patients who are treatment-naive or who have failed previous interferon-based therapy.
The panel also recommended screening patients for a genetic mutation called Q80K polymorphism that affects the effectiveness of simeprevir.
The FDA granted a Priority Review designation in May to simeprevir, an investigational NS3/4A protease inhibitor which has been developed by J&J’s Janssen unit and Sweden’s Medivir for the treatment of genotype 1 and genotype 4 chronic hepatitis C. It was approved in Japan for genotype 1 at the end of last month hepatitis C and has also been filed with the European Medicines Agency.
Later today, the FDA panel will give their opinion on Gilead Science’s much-touted hepatitis C drug sofosbuvir.
