Novartis has received a positive opinion supporting European Union regulatory approval for Lucentis? (ranibizumab) as a new treatment option for patients with the “wet” form of age-related macular degeneration, the leading cause of severe vision loss in people over age 50 in the western world.
The Committee for Medicinal Products for Human Use (CHMP), which reviews drug applications for all 25 countries in the European Union as well as Iceland and Norway, recommended approval of Lucentis. The European Commission generally follows the recommendation of the CHMP, and delivers its final decision within two to three months.
The positive opinion in Europe came only nine months after submission and comes after earlier approvals for Lucentis in Switzerland, India and the United States. Regulatory submissions for Lucentis have been based on three Phase III clinical trials, including two pivotal studies that were published in October 2006 in the New England Journal of Medicine.
“With Lucentis, the future of wet AMD treatment is certainly brighter than ever,” said Ursula Schmidt-Erfurth, MD, Professor and Chairman, Department of Ophthalmology, University of Vienna. “Lucentis gives real hope to wet AMD patients since it is the first and only therapy proven in clinical trials to help them regain vision on average. This means that many patients may regain the ability to do everyday activities such as reading, driving a car, cooking or going up and down stairs–ultimately helping to restore their independence.”
AMD is a degenerative eye disease that affects the macula – the central part of the retina at the back of the eye that is responsible for the “straight ahead” central vision necessary for everyday activities like reading, driving, telling time or identifying faces.
There are two types of AMD: dry and wet. Wet AMD accounts for about 15% of all AMD cases, but the majority of vision loss. It is associated with the growth of pathological new vessels under the macula that are fragile and leak fluid and blood. If not treated, scar tissue develops that destroys the macula.
“This positive recommendation highlights the important unmet need in the wet AMD patient population and the fact that Lucentis is a true breakthrough treatment,” said Nicholas Franco, Head of Novartis Ophthalmics. “Novartis now looks forward to final European Commission approval, and being able to provide European wet AMD sufferers access to Lucentis as quickly as possible.”