Lessons Learned: Santhera Will Refile Raxone For DMD In EU Next Year

 
• By Lucie Ellis-Taitt

Santhera plans to refile Raxone for the new indication of Duchenne muscular dystrophy with the European Medicines Agency in 2019 after the CHMP upheld its earlier negative opinion; the company's US regulatory strategy remains unchanged.

Dominos
CHMP setback: Santhera will regroup and try again with DMD drug in 2019 • Source: Shutterstock

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