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

Reuters

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

Their review was posted on the FDA website on Wednesdayahead of a meeting on Oct. 25 of an outside panel of medicalexperts who will recommend whether or not the agency shouldapprove the drug.

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

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