FDA approves simeprevir from Medivir, J&J
FDA approved an NDA from Johnson & Johnson (NYSE:JNJ) for Olysio simeprevir to treat chronic HCV genotype 1 infection in combination with interferon and ribavirin in patients with compensated liver disease. J&J plans to launch the second-generation HCV NS3/4A protease inhibitor in the U.S. in mid-December at a wholesale acquisition cost (WAC) of $22,120 for a month's supply. According to Olysio's label, the recommended treatment duration of the drug is 12 weeks.
On Wednesday, Health Canada approved simeprevir as Galexos to treat HCV genotype 1 infection in combination with interferon and ribavirin in patients with compensated liver disease who are treatment-naïve or who failed previous interferon-based therapy with ribavirin. The product is approved as Sovriad in Japan and is under review in the EU (see BioCentury, Nov. 11). ...