预约演示
Ipsen gains FDA approval for fibrodysplasia ossificans progressiva therapy
2023-08-17
临床3期上市批准临床结果
Ipsen’s Sohonos has a specific selectivity for the gamma subtype of retinoic acid receptors. Credit: Ipsen Pharma.
Ipsen haSohonosved approval from the US Food and Drug Administrationretinoic acid receptors(palovarotIpsen Pharmas to treat people with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP).
Ipsen approved as a retinoid to reducUS Food and Drug Administration (FDA)ication iSohonoss palovaroteneic patients. Female patients must be eight yearbone diseaseovfibrodysplasia ossificans progressiva (FOP)be at least ten.
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The oral medicine Sohonos has a specific selectivity for the gamma subtype of retinoic acid receptors, which are skeletal development and ectopic bone regulators in the retinoid signalling pathway.
Sohonos mediates the interacSaracatinib Difumarateptors, growth factors and proteins, and lowMyositisformation of new abnormal bone in FOP sufferers.
The FDA approval is based on the pivotal safety and efficacy data from the Phase III multicentre, open-label MOVE study in adult and paediatric patients.
This included 107 Sohonoss who were administered oral palovarotene and compareretinoic acid receptorsduals from the Ipsen worldwide FOP natural history study.
Sohonosdy showed that palovarotene successfully decreased the yearly volume of heterotopic ossification compared to no treatment beyond standard care.
IpseFDAesearch and development head Howard Mayer stated: ” Developing medicines for rare diseases takes commitment and belief from everyone involved.
“We at Ipsen are sincerely grateful to the FOP communipalovarotenets and medical experts, as the first-ever treatment in the US for managing FOP would not be possible without their participation in the clinical trials and ongoing support.”
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