In Canada, a priority review is generally reserved for drugs intended to treat serious or life threatening conditions. 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 age-related macular degeneration (AMD).
A priority review means that Health Canada could approve Lucentis in approximately 200 days following acceptance of the file, potentially making it available much sooner to patients. Lucentis has been approved for the treatment of wet AMD in Switzerland and the US while the submission for the EU was filed in March 2006.
The Lucentis filing is based on two phase III studies which demonstrated that up to 96% of Lucentis treated patients maintained or gained vision.
“The clinical trial results with Lucentis are better than anything we have ever seen in AMD. Not only does the drug virtually eliminate the risk of disease progression and visual loss, it also for the first time offers our patients a realistic opportunity for visual improvement which is truly a big advance in our ability to treat patients with wet AMD,” said Dr David Chow, assistant professor at the University of Toronto.
AMD is the leading cause of vision loss in Canada for people over the age of 50.