Clementia Granted Rare Pediatric Disease Designation by FDA for Palovarotene for Fibrodysplasia Ossificans Progressiva
CLEMENTIA PHARMACEUTICALS INC COMMON SHARES (CMTA)
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Source: GlobeNewswire
MONTREAL, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (Nasdaq: CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP). Palovarotene, an investigational therapy for FOP, has previously been granted Orphan Drug, Fast Track and Breakthrough designations by the FDA for FOP. “FOP is a rare, devastating disease that begins to irreversibly impact individuals in childhood,” said Clarissa Desjardins, Ph.D., founder and chief executive officer of Clementia. “The receipt of this designation highlights the urgent need for a treatment for people with FOP. The entire Clementia team is working towards an NDA submission in the second half of 2019 in hopes of achieving our first regulatory approval, an importa
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