The U.S. Food and Drug Administration (FDA) has granted priority review status to Medivir, in partnership with Janssen, for the supplemental New Drug Application (NDA) for Olysio (simeprevir) and Sovaldi (sofosbuvir) to treat genotype 1 of hepatitis C virus (HCV). On May 7, Medivir and Janssen filed the supplemental NDA for the 12-week, all-oral, interferon- and ribavirin-free regimen of the companies’ NS3/4A protease inhibitor Olysio and Gilead Sciences’ nucleotide analog polymerase inhibitor Sovaldi. The combination has already been widely prescribed off-label, but the FDA’s imprimatur would allow direct marketing of Olysio for this use.

The NDA was based upon data from the Phase II COSMOS study of treatment-naive participants with advanced fibrosis as well as people who did not respond to a previous attempt at a cure who had all stages of liver fibrosis. Ninety-three percent of those participants taking the regimen for 12 weeks and who did not take ribavirin achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). http://www.hepmag.com/articles/Olysio_Sovaldi_2501_25501.shtml

The FDA grants priority review to drugs that may offer a major advance in treating a condition. By law, the FDA review begins about 60 days after the new drug application with a goal of completing the process within six months. So the review should be underway by now, with an expected decision arriving by January.

“The priority review designation by the FDA shows the high priority and great importance of making interferon-free treatment regimens available to the many difficult-to-cure hepatitis C patients groups,” Charlotte Edenius, MD, PhD, executive vice president of development at Medivir, said in a release.

To read the press release, click here.