FDA Grants Faster Review for Gilead's Hepatitis C New Drug Application

The US Food and Drug Administration has granted Gilead Sciences priority review of a New Drug Application that seeks approval of its combination drug to treat all genotypes of chronic hepatitis C infection, the company announced.

The investigational regimen outlined in the NDA was granted breakthrough therapy designation by the FDA roughly two months after it was submitted in late October, according to Gilead. The agency grants the designation for investigational drugs that would significantly improve the safety or effectiveness of the treatment of a serious condition when compared to standard applications.

The past two years have seen a revolution of sorts in the treatment of hepatitis C with the development and approval of new yet pricey drugs that have much higher cure rates. The new direct-acting antiviral drugs also work faster and have fewer side effects than standard treatment from years past.

Hepatitis C is a liver-damaging bloodborne virus with a high degree of genetic diversity that is known to vary from one country to the next. There is no single drug currently on the market that is approved to treat all six genotypes of the virus.

If approved, the Gilead regimen could be the first pan-genotypic drug for hepatitis C to hit the market. The pharmaceutical company Merck is also working to develop a one-pill drug that could potentially treat multiple genotypes of the virus.

The faster review time for Gilead’s NDA means federal regulators could decide whether to approve the drug by this summer. The FDA has set a target action date of June 28, 2016, in keeping with requirements of the Prescription Drug User Fee Act (PDUFA), according to a statement released by Gilead.

The drug combination remains an investigational product and its safety and efficacy have yet to be established, Gilead noted in the release. The company also has submitted a marketing application to the European Medicines Agency (EMA) for evaluation of the same investigational drug, the release states.

The investigational drug under review is a once-daily fixed-dose combination of Gilead’s blockbuster Sovaldi, a nucleotide analog polymerase inhibitor known generically as sofosbuvir and the NS5A inhibitor velpatasvir, which is an investigational drug for the treatment of six genotypes of the hepatitis C virus. Sovaldi received FDA approval nearly two years ago and velpatasvir is a drug that is under development by Gilead and has not received regulatory approval.

Data submitted with the NDA comes from the company’s four Phase 3 ASTRAL trials that investigated 12 weeks of the sofosbuvir/velpatasvir in patients with chronic infection of HCV infection genotypes 1 through 6, the release states. The study populations include patients with compensated cirrhosis and those with decompensate cirrhosis whose treatment also included ribavirin, according to an earlier Gilead statement that announced the NDA filing.