HEALTH CANADA GRANTS NOVARTIS' LUCENTIS APPLICATION PRIORITY REVIEW

Novartis Ophthalmics Canada announced that Health Canada has granted priority review to Lucentis (ranibizumab), a treatment for neovascular (wet) age-related macular degeneration (AMD). In Canada, priority review is generally reserved for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Based on clinical trial data, Lucentis has the potential to provide a significant clinical advantage over existing therapies by improving vision in people suffering from wet AMD.

Lucentis is a humanized monoclonal antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor A (VEGF-A), the molecule believed to be the underlying cause of the wet form of AMD.

Priority review means that Health Canada could approve Lucentis in approximately 200 days following acceptance of the file. Lucentis has been approved for the treatment of wet AMD in Switzerland and the United States, while an application in the European Union was filed in March.

The Canadian filing is based on two Phase III, multicentre, randomized, double-blind studies in 1,139 wet AMD patients that compared Lucentis treatment with placebo (the MARINA trial) or active control (the ANCHOR trial). In these two pivotal Phase III clinical trials, up to 96 percent of Lucentis-treated patients maintained or gained vision.