Friday, June 7, 2013
FDA grants priority review status to Gilead's hepatitis C drug
(Reuters) - Biotechnology company Gilead Sciences Inc said the U.S. Food and Drug Administration (FDA) granted priority review to its experimental hepatitis C drug sofosbuvir.
The FDA grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.
The FDA set a review date of December 8 for the drug, Gilead said.
Gilead's oral drug is considered the most advanced and high-profile of treatments free of interferon, a standard hepatitis C drug which has side effects including colds and muscle fatigue.
Drugmakers AbbVie and Bristol-Myers Squibb are also developing such treatments but they require patient to take more pills each day than Gilead's treatment.
(Reporting By Vrinda Manocha in Bangalore; Editing by Don Sebastian)
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