FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

US anti-virals major Gilead Sciences (Nasdaq: GILD) says that the US Food and Drug Administration has granted priority review to the company’s New Drug Application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg for the treatment of chronic hepatitis C genotype 1 infection in adults.

Gilead filed the NDA for LDV/SOF earlier this year (The Pharma Letter February 11) 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. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The data submitted in the NDA are from three Phase III studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Around 75% of people infected with HCV in the USA have the genotype 1 strain of the virus.