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FDA Advisory Committee Recommends Ipsen's Palovarotene as an Effective and Safe Treatment for FOP

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  • Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP)
  • Advisory committee further voted 11 for and 3 against on the benefits of palovarotene outweighing the risks, for the treatment of patients with FOP
  • FDA PDUFA action date is anticipated by August 16, 2023
Source
Globe Newswire

Ipsen doubles down on rare bone disease

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Ipsen clearly wants to be a big deal in the rare bone disease fibrodysplasia ossificans progressiva (Fop). But its move to license BLU-782 from Blueprint Medicines today raises questions about the $1bn it paid for Clementia in February. BLU-782 targets the genetic cause of Fop so could presumably risk making palovarotene, which Ipsen gained through Clementia, redundant. 

Source
EP Vantage

Clementia jumps on NDA plans for unmet rare bone disease

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Clementia Pharmaceuticals Inc. (NASDAQ:CMTA) climbed $4.16 (40%) to $14.50 on Wednesday after announcing regulatory plans for palovarotene that could put the therapy first in line to gain FDA approval for fibrodysplasia ossificans progressiva (FOP). Clementia announced the news after market close Tuesday.

Source
BioCentury