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
- It will be the first drug fully approved by the EMA for the progressive muscle degeneration disease
- A launch in Germany is scheduled for the
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion in favor of giving the green light to vamorolone, which will be marketed as Agamree for the treatment of DMD patients aged four and older. The recommendation for full approval, which is expected in the next couple of months, was based on the Phase IIb VISION-DMD trial and three open-label studies where 6mg/kg/day doses of vamorolone proved to be statistically better than placebo, meeting the primary endpoint of time to stand
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