Gilead Hepatitis C Treatment Designated for FDA Priority Review
April 07 2014 - 8:25AM
Dow Jones News
By Michael Calia
Gilead Sciences Inc. (GILD) on Monday said the Food and Drug
Administration has placed the company's new drug application for a
hepatitis C treatment under priority review.
Gilead said it expects the FDA's decision on the
ledipasvir-sofosbuvir combination by Oct. 10.
Gilead has also applied to market the drug in the European
Union. The European Medicines Agency validated the application late
last month, according to the company.
The FDA granted the drug a "breakthrough therapy" designation, a
label meant for experimental medicine that may offer large
treatment advances over other, already existing options.
Gilead has moved to capitalize on hepatitis C and cancer drug
development in recent years as the company has faced sluggish sales
growth in HIV drugs.
Write to Michael Calia at michael.calia@wsj.com
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