Treatment for chronic hepatitis C earns FDA advisory committee approval
The once-daily treatment includes a combination of nucleotide analogue sofosbuvir and ribavirin. It has proved effective in the treatment of genotype 2 and 3 hepatitis C infections.
The advisory committee's recommendation isn't binding but will be considered by the FDA as it reviews the new drug application submitted by its developer Gilead Sciences, Inc. The FDA has granted the company a breakthrough therapy designation for the drug.
Breakthrough therapy designation and priority review status are awarded to pharmaceutical companies that develop new drugs that improve on existing treatment options.
The FDA has set a review date of Dec. 8 for the drug. Gilead Sciences has similar applications pending in Australia, Canada, the European Union, New Zealand, Switzerland and Turkey.
Sofosbuvir NDA has undergone phase 3 studies over the course of trial periods of therapy. Data showed that the drug performed better than other treatment methods currently on the market 12 weeks after treatment.
An additional phase 3 study showed that patients with genotype 3 hepatitis C achieved sustained virologic response after 24 weeks of Sofosbuvir NDA treatments.