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FDA grants priority review status to Gilead's hepatitis C drug
June 7, 2013 / 10:11 PM / 4 years ago

FDA grants priority review status to Gilead's hepatitis C drug

June 7 (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 Dec. 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.

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