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FDA grants priority review designation for lifitegrast
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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.
“Our NDA filing for lifitegrast represents an important regulatory milestone, exemplifying Shire’s ability to forge new paths in therapeutic areas aligned with our focus in rare and specialty conditions,” Philip J. Vickers, PhD, head of research and development for Shire, said in the release.
Based on the Prescription Drug User Fee Act V action date, the FDA would be expected to provide a decision on Oct. 25, according to the release.