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Santhera Sets Out Launch Strategy For CHMP-Backed Duchenne Drug

 
• By Kevin Grogan

In a major boost for Santhera and Duchenne muscular dystrophy patients, EU regulators have backed the firm’s Agamree for children aged four years and older and a launch in Germany is scheduled for January.

Eklund_Dario_1200
CEO Dario Eklund • Source: Santhera

Santhera Pharmaceuticals is set to hit the ground running with the launch of vamorolone now that regulators in Europe have recommended approval of the Swiss group's Duchenne muscular dystrophy (DMD) treatment.

Key Takeaways
  • The CHMP has backed Agamree for DMD and marketing authorization is expected late 2023

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion in favor of...

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