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FDA to consider approval of sofosbuvir as HCV treatment

Gilead Sciences is seeking FDA approval of nucleotide analogue inhibitor sofosbuvir for the treatment of chronic hepatitis C, according to a press release.

The direct-acting agent is intended for use as a once-daily, all-oral therapy among patients with chronic HCV genotypes 2 and 3, and also as combination therapy with pegylated interferon and ribavirin among those with genotypes 1, 4, 5 and 6.

In its new drug application, Gilead provided data from the phase-3 NEUTRINO, FISSION, POSITRON and FUSION studies, all of which indicated the efficacy of a 12-or 16-week sofosbuvir-based regimen to be similar or superior to that of current treatment options.

“Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate,” John C. Martin, PhD, chairman and CEO of Gilead, said in the release. “Sofosbuvir’s antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease.”

The company also plans to seek international approval for sofosbuvir during the second quarter of this year, according to the release. In the European Union, the European Medicines Agency has granted accelerated assessment for the drug, which could shorten the time for review by 2 months.