Sanofi: Japan approves Xenpozyme to treat acid sphingomyelinase deficiency


PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi announced on Monday that the Japanese Ministry of Health, Labor and Welfare had granted marketing authorization for its drug Xenpozyme (molecule olipudase alpha ), for the treatment of adults and children with acid sphingomyelinase deficiency without neurological manifestations.

Acid sphingomyelinase deficiency is a genetic, progressive, rare and potentially fatal lysosomal storage disease.

“Xenpozyme is currently the only drug approved for the treatment of this disease, in addition to being the first drug from Sanofi approved under the Sakigake program (‘pioneer’ in Japanese), an accelerated evaluation scheme set up by the Japanese government to promote research and development of new innovative drugs to meet unmet medical needs,” the group said in a statement.

Outside of Japan, the olipudase alpha molecule is evaluated by different regulatory bodies. The biologics license application has been accepted by the US Food and Drug Administration (FDA), which has granted it priority review and is expected to issue its decision early in the third quarter of this year. The European Medicines Agency has granted Priority Medicines Status (PRIME) to olipudase alfa. His decision is expected in the second half of 2022.

On the Paris Stock Exchange, Sanofi shares rose 1.3% to 94.34 euros.

-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: ECH

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March 28, 2022 03:23 ET (07:23 GMT)



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