First ASMD treatment Xenpozyme to land in Korea
By Eo, Yun-Ho | translator Alice Kang
22.11.23 16:33:30
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Sanofi Genzyme undergoes approval process by MFDS
Received breakthrough therapy designation in the US and Europe... the only existing treatment option available for the indication
According to industry sources, Sanofi Genzyme¡¯s treatment for acid sphingomyelinase deficiency (ASMD) ¡®Xenpozyme (olipudase alfa)¡¯ is undergoing processes for marketing authorization by the Ministry of Food and Drug Safety.
Starting with Japan in March, the drug was also approved in Europe in July and by the US FDA in August and received Breakthrough Therapy designation in the countries.
The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials.
The ASCEND trial evaluated the efficacy and safety of Xenpo
Eo, Yun-Ho(unkindfish@dailypharm.com)
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