EMA's CHMP reviewing Adakveo authorization after trial failure

30 January 2023

Preliminary results from the ongoing global Phase III STAND study in sickle cell disease are not what Novartis (NOVN: VX) had hoped.

The results indicate no statistically-significant difference between Adakveo (crizanlizumab) at 5mg/kg or 7.5mg/kg and placebo in annualized rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization.

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.

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