Posted by Michael Wonder on 25 Jul 2020
Novartis Adakveo receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
24 July 2020 - If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe.
Novartis announced today that the CHMP of the EMA 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. Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.
The CHMP opinion was based on results of the 52-week, randomised, placebo-controlled SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of vaso-occlusive crises to 1.63 vs 2.98 compared to placebo (P=.010), equivalent to a 45% reduction.
