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EMA ‘Extremely Collaborative And Well Prepared’ During Review Of Santhera’s DMD Drug Agamree

 
• By Eliza Slawther

Santhera Pharmaceuticals’ Agamree is on track to receive pan-EU approval to treat Duchenne muscular dystrophy before the year-end. The company’s CEO and CMO tell the Pink Sheet about its regulatory experience and future market access strategy.

Cogs
• Source: Shutterstock

Doctors face a serious conundrum when treating children with Duchenne muscular dystrophy (DMD). From a disease progression standpoint, the sooner they begin treatment with corticosteroids such as prednisone, which is used off-label to treat the condition, the better. But the side effects associated with these steroids can be extreme, and for many patients intolerable.

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