🇪🇺 XENPOZYME in European Union

EMA authorised XENPOZYME on 24 June 2022

Marketing authorisation

EMA — authorised 24 June 2022

  • Application: EMEA/H/C/004850
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Xenpozyme
  • 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.
  • Pathway: orphan, PRIME
  • Status: approved

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XENPOZYME in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is XENPOZYME approved in European Union?

Yes. EMA authorised it on 24 June 2022.

Who is the marketing authorisation holder for XENPOZYME in European Union?

Sanofi B.V. holds the EU marketing authorisation.