EMEA Validates NicOx’ MAA For Naproxcinod

NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the FDA in November 2009.

The company said that the MAA file is supported by data from a large program of 34 clinical trials, that involved more than 4,000 subjects treated with Naproxcinod. The program evaluated the efficacy of Naproxcinod in relieving signs and symptoms of osteoarthritis, as well as its safety, with a particular care given to its effect on blood pressure.

NicOx has submitted a New Drug Application (NDA) for Naproxcinod to the FDA in September 2009, and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) in December 2009, following the successful completion of three pivotal phase 3 studies.

Reportedly, the NDA for Naproxcinod was accepted for filing by the FDA in November 2009, and the agency has set a target date of July 24, 2010, for the completion of its review. The MAA was validated by the EMEA in January 2010. The FDA and the EMEA will evaluate the data submitted. NicOx does not wish to make any claims in regard to Naproxcinod’s safety or efficacy prior to its potential approvals.

Philippe Serrano, vice president of regulatory affairs at NicOx, said: “The validation of our European application for Naproxcinod is a key milestone that follows the acceptance of the NDA for filing in last November. Both the EMEA and the FDA are now reviewing the Naproxcinod data and we will be pleased to work together with them throughout this process.”