China's NMPA accepts Santhera's NDA for vamorolone, a potential Duchenne muscular dystrophy treatment, for priority review.
Santhera's NDA for vamorolone, a potential Duchenne muscular dystrophy treatment, has been accepted for priority review by China's NMPA. China's drug authority granted Breakthrough Therapy status to vamorolone, which has no approved drug for the condition's 70,000 patients in the country. Sperogenix Therapeutics holds exclusive rights for vamorolone in China, aiming for approval by Q1 2025.
March 27, 2024
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