.png)
Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on ADAKVEO (crizanlizumab) - Direct communication with healthcare professionals on ADAKVEO (crizanlizumab)
Direct communication with healthcare professionals on ADAKVEO (crizanlizumab)
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.
Published on: 15 June 2023
Contacts
Via del Tritone, 181 00187 Roma
VAT number: 08703841000
Tax code: 97345810580
IPA AIFA code: aifa_rm
IPA UCB code: UFE1TR