Drugs

FDA Oks Ipsen’s Sohonos for FOP

FDA has approved Ipsen’s NDA for Sohonos (palovarotene) capsules as a retinoid indicated to reduce in volume new heterotopic ossification in adults and pediatric patients aged 8 and older for females and 10 and older for males with fibrodysplasia ossificans progressiva (FOP). The company says it is the first treatment for FOP approved by the agency.

Ipsen says the approval is based on efficacy and safety data from the pivotal Phase 3 MOVE trial. “The study results demonstrated palovarotene effectively reduced annualized heterotopic ossification volume compared with no treatment beyond standard of care,” it says. “The study also demonstrated that palovarotene has a well-characterized safety profile, with adverse events consistent with the systemic retinoid class.”

Sohonos is described as an oral medicine with particular selectivity for the gamma subtype of retinoic-acid receptors, which are an important regulator of skeletal development and ectopic bone in the retinoid signaling pathway. It is designed to mediate the interactions between the receptors, growth factors, and proteins within the retinoid signaling pathway to reduce new abnormal bone formation in FOP, Ipsen says.

The drug received both orphan drug and breakthrough therapy designations from FDA for FOP and the NDA received priority review.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome