FDA grants priority review for Shire’s lifitegrast NDA to treat dry eye disease in adults

If approved, lifitegrast has the potential to be the first treatment indicated to address both signs and symptoms of the disease.

Lifitegrast is a new small-molecule integrin inhibitor which binds to the lymphocyte function-associated antigen-1 (integrin LFA-1) and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1).

Based on the Prescription Drug User Fee Act V action date, the FDA is expected to provide a decision on 25 October 2015.

The NDA submission is based on data from four clinical trials, which include one Phase II trial, two Phase III efficacy and safety trials, and one long-term Phase III safety trial, which involved more than 1,800 patients.

Shire Research and Development head Philip Vickers said: "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.

"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 company said that LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.

Image: Shire location in Lexington Massachusetts, US. Photo: courtesy of John Phelan.