Gilead: Sofosbuvir for Hepatitis C Granted FDA Priority Review

Gilead's investigational nucleotide hepatitis C virus (HCV) polymerase inhibitor sofosbuvir (formerly GS-7977) has been given priority review status by the U.S. Food and Drug Administration, with a target date in early December, the company announced last week.

Sofosbuvir has demonstrated promising activity in clinical trials to date, both as an add-on to interferon-based therapy and as a component of interferon-free regimens with agents including ledipasvir and daclatasvir.

In early April, Gilead submitted a New Drug Application requesting approval of sofosbuvir as part of interferon-free therapy with ribavirin for people with HCV genotypes 2/3 or a shorter interferon-based regimen for those with harder-to-treat genotypes.

Below is an edited excerpt from a Gilead press release announcing the FDA decision.

Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

Foster City, Calif. -- June 7, 2013 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.

The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naive patients with genotype 1, 4, 5 and 6 HCV infection.

Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

6/13/13

Source

Gilead Sciences. Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C. Press release. June 7, 2013.