NOVARTIS' LUCENTIS GETS FIRST EUROPEAN APPROVAL IN SWITZERLAND
Switzerland has become the first European country to approve Novartis and Genentech's Lucentis (ranibizumab) for the treatment of wet age-related macular degeneration, a leading cause of blindness in people over age 50. The company will begin supplying Lucentis in the middle of September in Switzerland.
The decision by the Swiss Agency for Therapeutic Products comes shortly after the U.S. FDA approved the drug in June. Swiss drugmaker Novartis has also submitted Lucentis for approval in the European Union and Australia. Genentech has the commercial rights to Lucentis in the U.S., while Novartis has exclusive rights in the rest of the world.
The Swiss approval of Lucentis
was based on two Phase III clinical trials. A therapeutic antibody fragment designed
specifically for treating conditions of the eye, Lucentis blocks all biologically
active forms of vascular endothelial cell growth factor A , the molecule believed
to be the underlying cause of wet age-related macular degeneration.