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Sanofi Gaucher pill application gets priority FDA review
December 11, 2013 / 6:20 AM / 4 years ago

Sanofi Gaucher pill application gets priority FDA review

PARIS, Dec 11 (Reuters) - French drugmaker Sanofi said the U.S. Food and Drug Administration (FDA) has granted a six-month priority review status for its application for eliglustat, an experimental oral treatment for patients with Gaucher disease.

The “priority review designation” means the FDA’s goal is to take action on the application within six months, instead of 10 months under a standard review, Sanofi said in a statement on Wednesday.

Patients with Gaucher disease, a rare genetic disorder, are deficient in an enzyme that breaks down a certain type of fat, leading to potentially life-threatening organ damage and bone problems.

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