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

 
• By Eliza Slawther
  
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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.

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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.

This is where Santhera Pharmaceuticals’ Agamree (vamorolone) fits in, the company’s CEO Dario Eklund and CMO Shabir Hasham told...

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