The FDA has accepted for filing Shire's 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, 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 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 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 1,800 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, M.D., professor of ophthalmology at Baylor College of Medicine, Houston, Texas.
Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry eye, an often chronic and progressive ocular disease, is one of the most common complaints to eye care professionals, and represents a significant unmet need.