Xenpozyme (olipudase alfa)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- olipudase alfa
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Acid sphingomyelinase deficiency (ASMD) type A/B or type B
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 24 Jun 2022
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/004850
- ATC
- A16AB25
- Official record
- www.ema.europa.eu
Indication
Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.