Novartis recalls Adakveo in the UK

The UK subsidiary of Swiss pharma giant Novartis (NOVN: VX) is recalling Adakveo (crizanlizumab) 10mg/ml concentrate for solution for infusion, due to the benefit-risk balance of Adakveo no longer being considered favorable by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

This is because the Phase III study (STAND) of Adakveo in sickle cell disease patients with vaso-occlusive crises did not confirm its clinical benefit. As a consequence, the conditional marketing authorization for the drug in the UK is being revoked.

Clinicians and prescribers who initiated patients on Adakveo concentrate for solution for infusion should inform patients of the licence revocation and discuss alternative treatment options with them. No new patients should be started on Adakveo in the UK, the MHRA stated.