FDA grants priority review for Gilead Sciences' hepatitis C drug sofosbuvir

Gilead Sciences announced Friday that the FDA granted priority review to its experimental drug sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection. The US regulator set a review date of December 8 for the once-daily oral nucleotide analogue inhibitor, Gilead said.

The company added that data submitted in its application support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with ribavirin and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Gilead reported interim data in May for the mid-stage LONESTAR trial in which nearly all patients taking a fixed-dose combination of sofosbuvir and ledipasvir appeared to have eliminated the virus after either eight weeks or 12 weeks of treatment. The company indicated plans to start a Phase III study evaluating eight weeks of the therapy in patients with genotype 1 HCV.

In April, data from a study testing sofosbuvir with Bristol-Myers Squibb's daclatasvir showed that nearly all the patients who took the drug combination, with or without ribavirin, were virus-free 12 weeks after six months of treatment. Nonetheless, Gilead is focusing on developing a regimen containing only its own drugs, with chief scientific officer Norbert Bischofberger saying at the time that "we have been able to advance the development of [sofosbuvir and ledipasvir] much more quickly than would have been possible with any inter-company collaboration."

For related analysis please read: ViewPoints: New Hep C data validates Gilead's solo approach.

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