Ipsen’s Palovarotene Hit By FDA Clinical Hold
Analysts Cut Their Palovarotene Sales Projections
The US FDA has slapped a partial clinical hold on Ipsen’s palovarotene clinical trials in rare bone disorders in children less than 14 years old, due to bone growth concerns.
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Despite concerns over toxicity due to early growth plate closure in skeletally immature patients, Ipsen's CEO David Loew is confident that palovarotene will get through regulatory review for fibrodysplasia ossificans progressive.
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