Shire nabs priority review for potential blockbuster dry eye drug
- According to Shire, if approved, Liftegrast will be the first dry eye treatment designed to treat both the signs and symptoms of dry eye disease.
- The PDUFA date for Liftegrast is October 25, 2015.
- 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).
The clinical trial program that supports Shire's NDA for Liftegrast is comprised of more than 1,800 patients. All told, there is one phase II study, two phase III safety and effectiveness studies and one long-term, phase III study. Instead of simply addressing the symptoms of dry eye disease, which include discomfort, visual disturbance and tearfilm instability, Liftegrast is also designed to treat the osmolarity of the tear film, as well as the inflamation of the ocular surface.
Shire has the opportunity to bring Liftegrast to market more quickly, because the Priority Review designation has decreased the review time by four months from a 12-month review to an 8-month review.
- streetinsider.com Shire (SHPG): FDA Grants Priority Review to Lifitegrast NDA