FDA Grants Breakthrough Therapy Designation to Clementia's Palovarotene

New developments after evaluation of preliminary study data

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to palovarotene for the prevention of heterotopic ossification (HO) in patients with FOP.  Breakthrough Therapy Designation is different than regulatory approval and given to drugs that are being developed for a serious condition, like FOP, and have shown preliminary clinical evidence of substantial improvement over available therapies. Palovarotene's designation was granted by the U.S. FDA after evaluation of preliminary Phase 2 study data. Congratulations to Clementia for achieving this important milestone in their continued FOP clinical trial work!


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