Santhera Announces Launch of Early Access Program in China for AGAMREE® by its Partner Sperogenix [Yahoo! Finance]
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Source: Yahoo! Finance
Early Access Program (EAP) for AGAMREE® (vamorolone) in China for patients with Duchenne muscular dystrophy (DMD). In April 2024, the Hainan Medical Products Administration (HMPA) authorized the EAP for AGAMREE based on local policies, AGAMREE's existing overseas approvals (U.S., EU, UK) and its demonstrated ability to address urgent clinical needs in DMD, where approved treatments are currently unavailable in China. The EAP has started in the Bo'ao Lecheng Pilot Zone, located in Hainan Province, in mid-May, when the first patients were treated with AGAMREE. In March 2024, the National Medical Products Administration (NMPA) accepted the new drug application (NDA) filing for AGAMREE in DMD for patients aged 4 years and older, incorporating it into both the Priority Review Program and the Breakthrough Therapy Program. Subject to a positive review outcome, approval could be obtained by Q1-2025. Duchenne muscular dystrophy is a rare neuromuscular disease affecting about 70,000 patie
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CPRX
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- 5/8/24 - Beat
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- 6/7/24 - Form 144
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