French Nicox SA withdraws EU MAA
Sophia Antipolis – French nitric oxide-donating drug specialist NicOx S.A. has withdrawn the EU Marketing Authorization Application (MAA) for ist osteoarthritis candidate naproxcinod (Beprana) after a meeting of the European Medicine’s Agency’s CHMP. The committee said the submitted data were not sufficient to adopt a formal positive opinion. NicOx is now evaluating its options for the potential further development of naproxcinod in Europe, together with its advisors and with Grupo Ferrer Internacional S.A. which has an option for rights to naproxcinod in certain European countries. In July 2010 the FDA said it would not approve the drug based on the data submitted for a New Drug Application. The company is currently finalising the submission of supporting information. The EMA said it will publish the reasons for its decision by mid-May. Previous clinical trials pointed to the possibility that it might be not easy to get the drug approved.