Adakveo

RSS

crizanlizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 24/11/2020

Authorisation details

Product details
Name
Adakveo
Agency product number
EMEA/H/C/004874
Active substance
Crizanlizumab
International non-proprietary name (INN) or common name
crizanlizumab
Therapeutic area (MeSH)
Anemia, Sickle Cell
Anatomical therapeutic chemical (ATC) code
B06AX01
Additional monitoringAdditional monitoring

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.

Conditional approvalConditional approval

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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
28/10/2020
Contact address

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

28/10/2020 Adakveo - EMEA/H/C/004874 -

Contents

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Pharmacotherapeutic group

Other hematological agents

Therapeutic indication

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.

Assessment history

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