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 benefit-risk balance of Adakveo is no longer favourable and the marketing authorisation in the EU will be revoked. 

No new patients should be started on Adakveo in the EU. Prescribers should inform patients currently on treatment with Adakveo, and discuss alternative treatment options with them.