Uncategorized
FDA grants priority review designation for lifitegrast
The FDA has accepted Shire’s new drug application and granted priority review designation for lifitegrast to treat dry eye disease in adults, according to a company release.Lifitegrast, a novel small-molecule integrin inhibitor, is being investigated for its potential to treat both signs and symptoms of dry eye disease, with the NDA filing being supported by evidence from one phase 2 and three phase 3 studies encompassing more than 1,800 patients, according to the release.