NicOx has submitted a marketing authorization application (MAA) for naproxcinod to the European Medicines Agency (EMEA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a New Drug Application (NDA) to the FDA in September, that has recently been accepted for filing.
Naproxcinod is NicOx’s new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators). 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.
Philippe Serrano, vice president of regulatory affairs at NicOx, said: “As planned, we have ended 2009 with the regulatory submissions for naproxcinod both in Europe, where we have just submitted an MAA through the centralized procedure, as well as the US, where the FDA has recently accepted our NDA for filing.”
Pascal Pfister, chief scientific officer and head of research & development at NicOx, said: “We are proud of all the achievements of our team during these last few years, including the completion of these important milestones on time. We will enter 2010 with confidence and are looking forward to working with the FDA and the EMEA during their review of the naproxcinod data.”