FX.co ★ Santhera : Vamorolone NDA Accepted For Priority Review By China' NMPA In Duchenne Muscular Dystrophy

Santhera Pharmaceuticals announced that the China National Medical Products Administration, or NMPA, has granted priority review status to the new drug application (NDA) for vamorolone. This drug is being designed to treat Duchenne muscular dystrophy (DMD) and the application was submitted by Sperogenix Therapeutics, Santhera's Chinese partner specializing in rare diseases.

The Chinese drug authority, NMPA's Center for Drug Evaluation (CDE), has given its approval for priority review of vamorolone for DMD patients aged four and above. With a positive result, the drug could be approved by the first quarter of 2025. Interestingly, vamorolone was previously included in the CDE's Breakthrough Therapy Program, which targets serious diseases that lack effective treatments and prioritizes drugs that provide clear clinical advantages.

DMD is a rare neuromuscular disorder affecting approximately 70,000 patients in China. The lack of an approved drug for the treatment of DMD in China has resulted in a significant medical need and therapeutic gap. This need is further amplified given the increase in diagnosis rates, allowing more patients to access specialized treatment centers.

Under a license agreement first announced in January 2022, Sperogenix Therapeutics has received exclusive development and commercialization rights for vamorolone in DMD and other rare disease contexts in China. Once commercialized, Sperogenix will pay Santhera based on sales milestones and double-digit percentage royalties on net sales.

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