Childhood dementia Tx Xenpozyme to soon land in KOR
By Eo, Yun-Ho | translator Kim, Jung-Ju
23.03.08 16:49:29
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MFDS conducts review for final approval
Received Breakthrough Therapy designation from the FDA... the only existing treatment option
According to industry sources, the Ministry of Food and Drug Safety is conducting the final review to approve Sanofi Genzyme¡¯s treatment for acid sphingomyelinase deficiency (ASMD)m ¡®Xenpozyme (olipudase alfa).¡¯
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 drug received final review in July and September in Europe and the US, respectively.
The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials.
Eo, Yun-Ho(unkindfish@dailypharm.com)
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