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Ipsen’s Sohonos Clinches First US Approval For Ultra-Rare Bone Disorder

Despite Chequered Past

 
• By Ayisha Sharma

Just a month after an EU rejection, the French drugmaker’s oral retinoic acid receptor gamma agonist Sohonos has won a US thumbs up for the treatment of fibrodysplasia ossificans progressiva, an ultra-rare disorder that turns soft tissue into bone.  

scan image of bone growth plate
The Label Has A Warning For Premature Growth Plate Closure In Children • Source: Shutterstock
Key Takeaways:

  • The approval follows an ultimately positive but hotly debated AdComm meeting in June.

  • Sohonos could have an annual price tag of $500,000.

  • The label carries black box warnings for premature growth plate closure in children and embryo-fetal toxicity.

Ipsen SA’s Sohonos has overcome controversies surrounding its pivotal development to become the first US Food and Drug Administration-approved

An estimated 900 people worldwide have FOP, which triggers new bone formation in soft and connective tissues, a process known as heterotopic ossification (HO)

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