Table of contents
Adakveo is a medicine for preventing painful crises in patients with sickle cell disease aged 16 years and older.
Sickle cell disease is a genetic condition in which the red blood cells become rigid and sticky and change from being disc-shaped to being crescent-shaped (like a sickle). They can block the flow of blood in blood vessels, causing painful crises that affect the chest, abdomen and other parts of the body.
Adakveo can be used as an add-on treatment with hydroxycarbamide (also known as hydroxyurea) or on its own in patients for whom hydroxycarbamide does not work well enough or causes too many side effects. Adakveo contains the active substance crizanlizumab.
Sickle cell disease is rare, and Adakveo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 August 2012.
Adakveo : EPAR - Medicine overview (PDF/106.36 KB)
First published: 24/11/2020
Adakveo : EPAR - Risk-management-plan summary (PDF/126.49 KB)
First published: 24/11/2020
Last updated: 30/08/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Anemia, Sickle Cell
|Anatomical therapeutic chemical (ATC) code||
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
08/09/2022 Adakveo - EMEA/H/C/004874 - II/0007
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Other hematological agents
Adakveo is indicated for the prevention of recurrent vaso occlusive crises (VOCs) in sickle cell disease patients aged 16 years and older.
It 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.