Novartis received first European approval for Lucentis (ranibizumb) from Switzerland for the treatment of "wet" age-related macular degeneration (AMD), a leading cause of blindness in people over age 50. Novartis will begin supplying Lucentis in the middle of September in Switzerland.
The decision by the Swiss Agency for Therapeutic Products (Swissmedic) comes shortly after the US Food and Drug Administration (FDA) approved Lucentis in June 2006. Novartis has also submitted Lucentis for approval in the European Union and Australia. Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the US, while Novartis has exclusive rights in the rest of the world, a Novartis press release said.
"Lucentis is redefining the treatment standards as the first approved drug for wet AMD patients that has been shown to improve vision and return the ability to do life-affirming everyday activities such as reading," said Nicholas Franco, Head of Novartis Ophthalmics. "Novartis is committed to providing treatments for wet AMD to physicians and patients that are innovative, effective and safe. We are excited to make Lucentis available to patients with this devastating disease."
Swiss approval of Lucentis was based on two pivotal phase III clinical trials - Marina and Anchor. According to studies, more than 90 per cent of Lucentis-treated patients maintained vision as defined by a loss of less than 15 letters in visual acuity as measured by the ETDRS (Early Treatment of Diabetic Retinopathy Study) eye chart and more than 68 per cent of Lucentis-treated patients gained vision as defined by a gain of one or more letters in visual acuity. Further, up to 40 per cent of Lucentis-treated patients improved vision as defined by the gain of 15 letters or more in visual acuity.