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Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

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Trial Profile

Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Masitinib (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science

    • Most Recent Events

    • 17 Oct 2024 According to an AB Science media release, European Medicines Agency (EMA) confirmed a negative opinion for conditional marketing authorization of masitinib in treatment of amyotrophic lateral sclerosis (ALS), following a vote adopted during Committee for Medicinal Products for Human Use (CHMP) meeting on 14-17 Oct 2024.The Conditional Marketing Authorization of masitinib had been under review by CHMP in response to company's request for a re-examination of negative opinion issued in June 2024.
    • 31 May 2024 According to an AB Science media release, company provided a summary of the live webcast held on May 30, 2024, giving an update on the application for conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS) with provided this confirmatory study is positive
    • 29 May 2024 According to an AB Science media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a trending toward a negative opinion on the application for conditional marketing authorisation of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following an oral explanation held at the 28 May meeting of the CHMP. The CHMP is expected to adopt a formal opinion on the MAA at its next meeting, which will be held June 24- 27, 2024.

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