Switzerland first EU state to approve Novartis' Lucentis

Swiss drug major Novartis says that its home country has become the first in Europe to approve Lucentis (ranibizumab) for the treatment of wet age-related macular degeneration. The Swiss Agency for Therapeutic Products' (Swissmedic) decision, which follows approval by the US Food and Drug Administration earlier this year (Marketletter July 10), is based on data from two pivotal Phase III trials that demonstrated that a 0.5mg administration of the drug enabled more than 90% of patients to maintain vision, as defined by early treatment of diabetic retinopathy criteria. In addition, 68% of treated subjects showed improved visual acuity. The firm added that it has also submitted the drug to other regulatory approval bodies in both Europe and Australia.