Novartis seeks EU approval for Lucentis

Swiss drug major Novartis says it has submitted its biologic Lucentis (ranibizumab) to European regulatory authorities seeking approval for the products use in the treatment of neovascuolar age-related macular degeneration, the leading cause of blindness in people over 60 in the western world. The firm added that the filing is part of its overall strategy to gain worldwide approval for the product, and follows its recent submission to Switzerland's regulators in February this year.

Lucentis, which was originally developed by US biotechnology firm Genentech and licensed to Novartis under an agreement established in 2003 (Marketletter July 7, 2003), is a human monoclonal antibody fragment designed to bind and inhibit vascular endothelial growth factor receptor-A, thereby preventing abnormal blood vessel growth which leads to wet AMD and vision loss.

The European Union submission is based on data from two pivotal Phase III trials (MARINA and ANCHOR) which have shown that the drug has efficacy in maintaining or improving patient vision, with 96% of treated subjects achieving a measurable improvement in visual acuity. In addition, Novartis added that it will present full results at the Association for Research in Vision and Opthalmology meeting in Fort Lauderdale, USA, in April this year.