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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: 04 Feb 2019

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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 2019 Sanofi completes enrolment in the phase I/II ASCEND-Peds trial for Niemann-Pick disease type B in US, France, Italy, Brazil, Germany, United Kingdom and USA (NCT02292654)
  • 30 Jan 2019 Sanofi completes enrolment in the phase II/III ASCEND trial for Niemann-Pick disease type B in Australia, Chile, Germany, Italy, France, Netherlands, Japan, Portugal, Turkey, Spain, United Kingdom and USA (NCT02004691)
  • 07 Feb 2018 Sanofi announces intention to submit regulatory application for Niemann-Pick disease type B in 2020
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