Alcon withdraws EU Retaane MAA

Texas, USA-based Alcon has announced the withdrawal of its European marketing authorization application for Retaane (anecortave acetate suspension for depot injection) 30mg/ml from the European Medicines Agency (EMEA) review process. The company chose to withdraw the application after being informed by the Agency that it would have to provide additional clinical data from existing and/or new clinical trials to support approval. The US Food and Drug Administration also recently advised the company that additional clinical data will be required for domestic approval. The drug received an FDA "approvable" letter last year (Marketletter May 30, 2005).

The company said it is revising its clinical strategy and plans to continue developing Retaane suspension for wet age-related macular degeneration in the USA, Europe and key markets around the world. It added that it would provide a timeframe for resubmission or amendment after it finalizes the revised clinical development strategy.