Ipsen Initiates Partial Clinical Hold for Palovarotene IND120181 and IND135403 Studies
IPSEN SA S/ADR (IPSEY)
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Source: Business Wire
PARIS--(BUSINESS WIRE)--Regulatory News:Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following discussions with the U.S. Food and Drug Administration (FDA), that a partial clinical hold effective immediately, for the pediatric population under the age of 14 was issued for studies conducted under IND120181 and IND135403 evaluating the investigational drug candidate palovarotene for the chronic treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO), respectively. The partial clinical hold applies to the pediatric population (patients under the age of 14 years) currently participating in the Phase 2 (PVO-1A-202/204 and PVO-2A-201) and Phase 3 (PVO-1A-301) studies in all clinical sites at global level. The FDA is allowing the studies to continue to treat patients 14 years of age and older.The partial clinical hold was issued following recent safety reports submitted by the company to the FDA of cases of early growth plate closure in pediatric
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