US FDA accepts Shire's lifitegrast NDA and granted priority review status

Shire plc announced that the United States Food and Drug Administration (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 October 25, 2015, based on the Prescription Drug User Fee Act V action date.

The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months

“Our NDA filing for

The NDA filing is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These include one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study.
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, Ph.D., head of research and development, 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.”