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Olipudase alfa - Sanofi Genzyme

Drug Profile

Olipudase alfa - Sanofi Genzyme

Alternative Names: GZ-402665; Recombinant human acid sphingomyelinase - Sanofi Genzyme; rhASM - Sanofi Genzyme

Latest Information Update: 11 Apr 2020

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At a glance

  • Originator Genzyme Corporation
  • Developer Genzyme Corporation; Sanofi Genzyme
  • Class Sphingomyelin phosphodiesterases
  • Mechanism of Action Sphingomyelin phosphodiesterase stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Niemann-Pick diseases
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Niemann-Pick disease type B
  • No development reported Niemann-Pick disease type A

Most Recent Events

  • 30 Jan 2020 Sanofi announces intention to submit regulatory applications for Niemann-Pick disease type B in the second half of 2021
  • 30 Jan 2020 Positive top-line efficacy and adverse events data from the phase II/III ASCEND trial and the phase II ASCEND-Peds trial in Niemann-Pick disease type B released by Sanofi
  • 09 Dec 2019 Genzyme completes a phase II trial in Sphingomyelin lipidosis in the USA, Germany, Italy, Brazil, France and the UK (NCT02292654)
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