Key Takeaways
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The rejection follows on from a negative CHMP opinion issued in January.
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Ipsen went against FDA advice and designed a single-armed pivotal trial for palovarotene.
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A recent Adcomm meeting on the drug ended on a positive note despite some criticism.
After a controversial clinical development path, Ipsen SA’s palovarotene has been rejected in the EU for the treatment of the ultra-rare bone disorder fibrodysplasia ossificans progressiva (FOP), but an
FOP causes permanent new bone formation in the soft and connective tissues, a process known as heterotopic ossification (HO)
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