Gilead's hepatitis C drug safe, effective-FDA reviewers

Wed Oct 23, 2013 8:41am EDT

Oct 23 (Reuters) - Gilead Sciences Inc's drug sofosbuvir is safe and effective when used in combination with other therapies to treat hepatitis C, according to reviewers with the U.S. Food and Drug Administration.

Their review was posted on the FDA website on Wednesday ahead of a meeting on Oct. 25 of an outside panel of medical experts who will recommend whether or not the agency should approve the drug.

"The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C," the reviewers said. "No major safety issues associated with sofosbuvir use have been identified to date."