BIOPHYTIS receives orphan drug designation in the United States for Sarconeos in Duchenne muscular dystrophy (DMD) | DuchenneXchange

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BIOPHYTIS receives orphan drug designation in the United States for Sarconeos in Duchenne muscular dystrophy (DMD)


BIOPHYTIS, a biotechnology company specializing in the development of drug candidates to treat age-related degenerative diseases, announces that the FDA (Food and Drug Administration) has granted orphan drug designation to its drug candidate Sarconeos in Duchenne Muscular Dystrophy (DMD).

The orphan drug designation by the FDA will grant Sarconeos with the benefits associated with the status, in particular, a 7 years protection after marketing authorization, possible co-financing of clinical trials with the FDA and the possibility of an accelerated registration procedure. BIOPHYTIS has also filed an application for an orphan drug designation for Sarconeos in Duchenne myopathy with the EMA (European Medicines Agency). The Agency’s response is expected in the coming weeks.

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