French biotechnology firm NicOx (Euronext Paris: COX) has received a positive opinion from the European Union Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for naproxcinod for the treatment of Duchenne Muscular Dystrophy (DMD).
The orphan drug designation, given to products to be developed for life-threatening or very serious conditions that affect not more than five in 10,000 people in the European Union, allows companies to benefit incentives including a 10-year market exclusivity post-approval, scientific advice and fee reductions.
Naproxcinod, a CINOD (cyclooxygenase-inhibiting nitric oxide-donating) anti-inflammatory candidate, has shown promising preclinical results in models of muscular dystrophy. DMD is a chronically debilitating and life-threatening disease, characterized by rapidly progressive muscle weakness and wasting due to degeneration of skeletal, smooth and cardiac muscles.
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