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Novartis: CHMP Recommends Conditional Marketing Authorization Of Adakveo

Novartis (NVS) said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending conditional marketing authorization of Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises, or pain crises, in patients with sickle cell disease aged 16 years and older. The company noted that, if approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe.

The CHMP opinion was based on results of the 52-week, randomized, placebo-controlled SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of vaso-occlusive crises compared to placebo.

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