FDA Grants Priority Review To Gilead's Hepatitis C Drug Combo

The U.S. Food and Drug Administration (FDA) has granted priority review to Gilead Sciences’ New Drug Application (NDA) for ledispavir (LDV) and sofosbuvir (SOF) combination treatment for hepatitis C. Gilead said the FDA has set a target action date of October 10, 2014.

The company filed the NDA for once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg  intended to treat chronic hepatitis C genotype 1 infection in adults. Supporting data from three Phase III studies (ION-1, ION-2, and ION-3) support the use of LDV/SOF in adult patients with genotype 1 HCV infection. A treatment duration of eight or twelve weeks based on prior treatment history and the presence or absence of cirrhosis was suggested.

About 150 million are chronically infected with HCV, according to the World Health Organization. Over 350,000 people die from hepatitis C-related liver diseases every year, which can include cirrhosis of the liver or liver cancer. About three to four million people are infected with HCV every year. An estimated 75 percent of people infected with HCV in the U.S. have the genotype 1 strain of HCV.

The FDA has previously assigned Breakthrough Therapy status to LDV/SOF. The EMA has also accepted Gilead’s accelerated evaluation request for LDV/SOF. This could shorten the EMA’s review time by two months, though it is not a guarantee of a Committee for Medicinal Products for Human Use’s (CHMP) positive opinion or European Commission approval. The CHMP gave a positive recommendation on the use of a fixed-dose combination of ledipasvir and sofosbuvir in the treatment of chronic HCV infection in a compassionate-use program in February.

Sofosbuvir is approved by the FDA as a single agent under the brand name Sovaldi. LDV/SOF combination therapy is an investigational product with no established safety and efficacy profile.