NicOx files for European approval of naproxcinod in OA indication

French drug developer NicOx has submitted a Marketing Authorization Application (MAA) naproxcinod to the European Medicines Agency (EMEA) through the centralized procedure, 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 US Food and Drug Administration in September that has recently been accepted for filing, the Sophia Antipolis-headquartered company said.

NicOx shares rise as much as 9% to 5.89 euros yesterday on the news, trimming recent losses. "This filing is expected and does not contain a surprise," said CM-CIC Securities in a research note quoted by Reuters, rating the stock "buy" with a price target of 16 euros.

Naproxcinod is NicOx' lead investigational compound and the first in a 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.