UncategorizedUncategorizedClinical Trial Updates (SCD)

Adakveo®

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  • Product Information

    Product Information

    Scientific name: Crizanlizumab
    Brand name: Adakveo
    RESPONSIBLE: Novartis Pharmaceuticals Corp.

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Last update: 22/6/2023

    Trial Name: —
    Code: —
    Phase: —
    Eligible patient diagnosis: —
    No. of Patients enrolled: —
    Study Sites: — Sites per country

    Completion date: —
    Scope of the Study / Aim: —

  • Regulatory Information

    Regulatory Information

    Status: Authorised

    Additional notable points:

    • —

Update: 30 June 2023

No update available.

 

Update: 31 March 2023

Preliminary results from the ongoing global Phase III STAND study in sickle cell disease showed no difference between Adakveo and placebo in annual rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization.

Consequently, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a review of Adakveo to evaluate the impact of these results on its currently authorized use.

Adakveo was approved in the USA in November 2019 for the reduction in frequency of vaso-occlusive crises. In October 2020, the European Medicines Agency’s (EMA) granted conditional Marketing Authorization to prevent recurrent vaso-occlusive crises in patients aged 16 years and above, living with sickle cell disease.

Sources: https://www.thepharmaletter.com/article/ema-s-chmp-reviewing-adakveoauthorization-after-trial-failure
https://www.fiercepharma.com/pharma/novartiss-adakveo-couldnt-beat-placeboema-review-its-current-authorization

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