FDA priority review for Shire's Lifitegrast

The US Food and Drug Administration has accepted for filing Ireland-headquartered Shire’s (LSE: SHP) New Drug Application for Lifitegrast and granted a Priority Review designation.

The news pushed the drugmaker’s shares up nearly 4% to $256.71 yesterday in New York trading, reversing an earlier decline as a result of disappointing results for Shire’s Alagille syndrome drug candidate (The Pharma Letter April 9). In London this morning, the stock gained 4.5% to £56.60.

Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date.