FDA assigns priority review to combination ledipasvir + sofosbuvir for Hepatitis C- Gilead

Gilead Sciences, Inc. has announced that the FDA has granted priority review to the company�s New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic Hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. The FDA has also assigned LDV/SOF a Breakthrough Therapy designation.

If the FDA grants its approval to the ledipasvir/sofosbuvir fixed dose combination, it would be the first oral treatment regimen for patients with Hepatitis C genotype 1 infection in which the need for both interferon and ribavirin is eliminated.