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news.Swiss regulators have approved Novartis' Lucentis for the treatment of "wet" age related macular degeneration, a leading cause of blindness in people over 50. The approval marks the first European approval for the drug.
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Novartis will begin supplying Lucentis in the middle of September in Switzerland.
The decision by the Swiss Agency for Therapeutic Products comes shortly after the 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.
Novataris said it was excited to make the drug available to patients with the disease and give them the ability to perform everyday tasks such as reading.
Swiss approval of Lucentis was based on two pivotal phase III clinical trials. The two phase III studies showed more than 90% of Lucentis-treated patients maintained or gained vision
“Lucentis will change the way we treat our wet AMD patients,” said Dr Sebastian Wolf at the Inselspital Universität in Bern, Switzerland. “For the first time we can offer patients the hope that they will regain some vision, rather than just slow the loss of vision.”