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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

Following a re-examination, Santhera Pharmaceuticals AG'sRaxone (idebenone) has again been turned down by the European Medicines Agency’s scientific committee, the CHMP, for the additional indication of Duchenne muscular dystrophy – but the company's CEO believes the drug is at a natural disadvantage as the first mover in a novel area of DMD research.

Santhera’s application for Raxone in DMD was given a negative opinion by the CHMP in September 2017, but Santhera appealed the decision. Last week the committee upheld its original opinion,...

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