The US Food and Drug Administration (FDA) has granted approval to Switzerland-based Novartis' Adakveo (crizanlizumab) intended for use with sickle cell disease patients, it was reported yesterday.

The product was formerly called SEG101 and has been approved for decreasing the incidents of vaso-occlusive crises (VOCs) or pain crises in adult patients with sickle cell disease, aged 16 years and older. It binds to P-selectin, a cell adhesion protein that plays a key role in the multicellular interactions that possibly lead to vaso-occlusion.

The approval was based on the results of the 52-week, randomised, placebo-controlled SUSTAIN trial. During the phase two trial, the product was demonstrated to have considerably decreased the median annual rate of VOCs to 1.63 compared to 2.98 recorded in the placebo arm.