MONTRÉAL, QC – Shire Pharma Canada ULC has filed a New Drug Submission (NDS) with Health Canada for the marketing authorization of lifitegrast for the treatment of dry eye disease in adults in Canada.
Lifitegrast is novel small-molecule integrin antagonist. It inhibits the interaction between the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 may be over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.
The lifitegrast submission is supported by five clinical trials with more than 2,500 patients. These included one Phase 2 study, three Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study. The file is currently under review with Health Canada. If approved, Canada will be the first country to receive marketing authorization for lifitegrast after the United States.