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Santhera announces Early Access Program by partner Sperogenix for DMD treatment
Betsy Goodfellow | June 11, 2024 | News story | Medical Communications | DMD, Musculo-skeletal disorder, early access, muscular dystrophy, santhera
Santhera Pharmaceuticals has announced that its partner Sperogenix Therapeutics has launched a paid-for Early Access Program (EAP) for Agamree (vamorolone) in China for patients with Duchenne muscular dystrophy (DMD).
Previously, in April 2024, the Hainan Medical Products Administration (HMPA) authorized the EAP for Agamree, following existing approvals in the US, EU and UK. The EAP was initiated in the Bo’ao Lecheng Pilot Zone, located in the Hainan Province in May 2024.
As of March 2024, the National Medical Products Administration (NMPA) has accepted the new drug application (NDA) filing for Agamree in DMD for patients over the age of four, incorporating the drug into its Priority Review Program and its Breakthrough Therapy Program. Depending on the drug gaining a positive review, it could gain full approval by the first quarter of 2025.
The press release states: ‘According to the license agreement between the companies, first announced in January 2022, Sperogenix holds exclusive development and commercialisation rights to vamorolone in DMD and all other rare disease indications for China. Santhera is supplying treatment medication to Sperogenix for the EAP as well as for commercialisation. Sperogenix will pay Santhera double-digit percentage royalties on net product sales (including for the EAP) and additional revenue-dependent milestones on commercial sales’.
Betsy Goodfellow
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