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Xenpozyme FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 1, 2022.

FDA Approved: Yes (First approved August 31, 2022)
Brand name: Xenpozyme
Generic name: olipudase alfa
Dosage form: Lyophilized Powder for Injection
Company: Sanofi
Treatment for: Acid Sphingomyelinase Deficiency

Xenpozyme (olipudase alfa-rpcp) is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD).

Development timeline for Xenpozyme

Aug 31, 2022Approval FDA Approves Xenpozyme (olipudase alfa-rpcp) for Non-CNS Manifestations of Acid Sphingomyelinase Deficiency (ASMD)
Oct 27, 2020Olipudase Alfa Demonstrated Significant Improvement in Lung Function and Spleen Volume in Patients with ASMD
Jan 30, 2020Positive Topline Results Demonstrated by Olipudase Alfa, First and Only Investigational Therapy in Late-Stage Development for Acid Sphingomyelinase Deficiency

Further information

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