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EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos

 
• By Vibha Sharma

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OKd new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Fibrodysplasia Ossificans Progressiva. Doctor with rare or orphan disease text on tablet screen Fibrodysplasia Ossificans Progressiva
There Are No Disease-Modifying Treatment Options Available In EU For FOP • Source: Shutterstock

The European Medicines Agency has decided that Ipsen’s Sohonos (palovarotene) should not be authorized for use in the EU, but it has recommended in favor of approval for Bristol Myers Squibb’s Sotyktu (deucravacitinib).

Ipsen was seeking approval to use Sohonos for treating the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP)

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