Shire has announced that the FDA has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. 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 25 October 2015, based on the Prescription Drug User Fee Act V action date.
“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,” said Philip J. Vickers, Head of R&D, Shire. “Our commitment to moving lifitegrast forward reflects our intent to grow in the Ophthalmics therapeutic category in areas of unmet patient need. We look forward to working closely with the FDA throughout the review process.”
The NDA filing is supported by the totality of evidence from four clinical trials with more than 1800 patients. These include one Phase II study, two Phase III efficacy and safety studies, and one long-term Phase III safety study.
“The symptoms of dry eye are one of the most common complaints from patients, yet there remains a tremendous unmet need,” said Stephen C. Pflugfelder, Professor of Ophthalmology at Baylor College of Medicine, Houston, Texas. “It’s encouraging to see Shire moving the program for lifitegrast forward.”
