Ipsen Ends Trial of Pediatric Drug After FDA Partial Clinical Hold
Ipsen has terminated its trial of palovarotene for pediatric treatment of rare bone and tissue diseases after the FDA placed a partial clinical hold due to concerns about patient safety.
The FDA hold prohibited administration of the drug to children age 14 and younger due to fears that the drug may stunt the growth of children with multiple osteochondroma and fibrodysplasia ossificans progressiva (FOP).
Ipsen said the time that has elapsed since the clinical hold was put in place has created gaps in dosing, which may have compromised the integrity of the trial data. Additionally, no efficacy data were yet available when the partial hold was enforced, which may prevent the company from filing for FDA approval for the drug.