Adakveo

crizanlizumab

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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.

: Adakveo is given by infusion (drip) into a vein lasting 30 minutes and the dose depends on the patient’s weight. The first two infusions are given 2 weeks apart. Subsequent infusions are given every 4 weeks.

The medicine can only be obtained with a prescription. Treatment should be started by a doctor experienced in treating sickle cell disease.

For more information about using Adakveo, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Adakveo, crizanlizumab, is a monoclonal antibody (a type of protein) designed to attach to a substance, P-selectin, present on the surface of the cells lining blood vessels. P-selectin helps cells stick to the blood vessels and plays a role in the clogging up of vessels during painful crises in sickle cell disease. By attaching to and blocking the action of P-selectin, the medicine helps prevent painful crises.

: A main study in 198 patients with sickle cell disease showed that Adakveo was effective at reducing the number of painful crises. In this study, patients given Adakveo had on average 1.6 crises per year, while patients given placebo (a dummy treatment) had on average 3 crises per year.

The study also showed that Adakveo reduced the yearly number of crises by almost a third in patients already taking hydroxycarbamide (2.4 versus 3.6) and by half in patients not taking hydroxycarbamide(1 versus 2).

: The most common side effects with Adakveo (which may affect more than 1 in 10 people) are joint pain, nausea, back pain, fever and abdominal (belly) pain. Severe joint pain or fever may occur in around 1 in 100 people.

For the full list of side effects and restrictions, see the package leaflet.

: The main study showed that Adakveo was effective at reducing the number of painful crises in patients with sickle cell disease. There was some uncertainty about the size of Adakveo’s effect because of how the study was designed, but results showed consistent improvements with Adakveo, including a reduction in hospitalisations.

The side effects of Adakveo were relatively mild and considered manageable. The European Medicines Agency concluded that Adakveo’s benefits are greater than its risks and it can be authorised for use in the EU.

Adakveo has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

: Since Adakveo has been given conditional authorisation, the company that markets Adakveo will provide further data on the safety and effectiveness of the medicine from two additional studies.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adakveo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Adakveo are continuously monitored. Side effects reported with Adakveo are carefully evaluated and any necessary action taken to protect patients.

: Adakveo received a conditional marketing authorisation valid throughout the EU on 28 October 2020.

List item

Adakveo : EPAR - Medicine overview (PDF/208.21 KB)

First published: 24/11/2020
Last updated: 21/08/2023
EMA/446082/2020
- Bulgarian
  (PDF/258.53 KB)
- Croatian
  (PDF/222.55 KB)
- Czech
  (PDF/232.71 KB)
- Danish
  (PDF/192.47 KB)
- Dutch
  (PDF/195.9 KB)
- Estonian
  (PDF/172.19 KB)
- Finnish
  (PDF/187.61 KB)
- French
  (PDF/197.58 KB)
- German
  (PDF/201.08 KB)
- Greek
  (PDF/256.85 KB)
- Hungarian
  (PDF/226.21 KB)
- Italian
  (PDF/193.4 KB)
- Latvian
  (PDF/236.29 KB)
- Lithuanian
  (PDF/231.44 KB)
- Maltese
  (PDF/238.09 KB)
- Polish
  (PDF/233.87 KB)
- Portuguese
  (PDF/198.01 KB)
- Romanian
  (PDF/232.25 KB)
- Slovak
  (PDF/227.5 KB)
- Slovenian
  (PDF/228.97 KB)
- Spanish
  (PDF/196.57 KB)
- Swedish
  (PDF/192.38 KB)
List item

Adakveo : EPAR - Risk-management-plan summary (PDF/340.06 KB)

First published: 24/11/2020
Last updated: 21/08/2023

This EPAR was last updated on 29/09/2023

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 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 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.

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	6
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

03/08/2023 Adakveo - EMEA/H/C/004874 - 004874/A20/0013

List item

Adakveo : EPAR - Product information (PDF/1.36 MB)

First published: 24/11/2020
Last updated: 21/08/2023
- Bulgarian
  (PDF/1.59 MB)
- Croatian
  (PDF/1.82 MB)
- Czech
  (PDF/1.85 MB)
- Danish
  (PDF/1.35 MB)
- Dutch
  (PDF/1.3 MB)
- Estonian
  (PDF/1.3 MB)
- Finnish
  (PDF/1.3 MB)
- French
  (PDF/1.47 MB)
- German
  (PDF/1.4 MB)
- Greek
  (PDF/4.58 MB)
- Hungarian
  (PDF/1.47 MB)
- Icelandic
  (PDF/1.58 MB)
- Italian
  (PDF/1.92 MB)
- Latvian
  (PDF/1.36 MB)
- Lithuanian
  (PDF/1.46 MB)
- Maltese
  (PDF/1.77 MB)
- Norwegian
  (PDF/1.49 MB)
- Polish
  (PDF/1.66 MB)
- Portuguese
  (PDF/1.57 MB)
- Romanian
  (PDF/1.81 MB)
- Slovak
  (PDF/1.67 MB)
- Slovenian
  (PDF/1.58 MB)
- Spanish
  (PDF/1.48 MB)
- Swedish
  (PDF/1.42 MB)

Other EU languages available icon 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.

List item

Adakveo : EPAR - All authorised presentations (PDF/115.27 KB)

First published: 24/11/2020
Last updated: 21/08/2023
- Bulgarian
  (PDF/130.35 KB)
- Croatian
  (PDF/120.92 KB)
- Czech
  (PDF/122.23 KB)
- Danish
  (PDF/119.44 KB)
- Dutch
  (PDF/117.21 KB)
- Estonian
  (PDF/114.35 KB)
- Finnish
  (PDF/115.45 KB)
- French
  (PDF/118.57 KB)
- German
  (PDF/120.75 KB)
- Greek
  (PDF/126.63 KB)
- Hungarian
  (PDF/120.09 KB)
- Icelandic
  (PDF/116.95 KB)
- Italian
  (PDF/120.25 KB)
- Latvian
  (PDF/122.37 KB)
- Lithuanian
  (PDF/120.31 KB)
- Maltese
  (PDF/124.49 KB)
- Norwegian
  (PDF/121.81 KB)
- Polish
  (PDF/122.47 KB)
- Portuguese
  (PDF/119.5 KB)
- Romanian
  (PDF/121.18 KB)
- Slovak
  (PDF/122.07 KB)
- Slovenian
  (PDF/117.66 KB)
- Spanish
  (PDF/118.8 KB)
- Swedish
  (PDF/116.27 KB)

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

Changes since initial authorisation of medicine

List item

Adakveo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/238.21 KB)

First published: 05/07/2021
Last updated: 21/08/2023
List item

Adakveo Article-20 procedure - Annex - Scientific conclusions (PDF/182.79 KB)

First published: 09/08/2023
Last updated: 21/08/2023
- Bulgarian
  (PDF/230.15 KB)
- Croatian
  (PDF/208.58 KB)
- Czech
  (PDF/227.16 KB)
- Danish
  (PDF/188.81 KB)
- Dutch
  (PDF/200.26 KB)
- Estonian
  (PDF/162.9 KB)
- Finnish
  (PDF/176.13 KB)
- French
  (PDF/207.95 KB)
- German
  (PDF/220.44 KB)
- Greek
  (PDF/244.66 KB)
- Hungarian
  (PDF/202.69 KB)
- Italian
  (PDF/200.27 KB)
- Latvian
  (PDF/225.08 KB)
- Lithuanian
  (PDF/200.49 KB)
- Maltese
  (PDF/297.5 KB)
- Polish
  (PDF/214.25 KB)
- Portuguese
  (PDF/193.71 KB)
- Romanian
  (PDF/204.32 KB)
- Slovak
  (PDF/211.08 KB)
- Slovenian
  (PDF/201.8 KB)
- Spanish
  (PDF/181.21 KB)
- Swedish
  (PDF/187.77 KB)
List item

Adakveo Article-20 procedure - Assessment report (PDF/2.57 MB)

First published: 09/08/2023
Last updated: 21/08/2023
EMA/267688/2023
List item

Adakveo-H-C-PSUSA-00010888-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/178.29 KB)

First published: 30/08/2021
Last updated: 21/08/2023
EMA/CHMP/378769/2021

Adakveo

Table of contents

Overview

Adakveo : EPAR - Medicine overview (PDF/208.21 KB)

Adakveo : EPAR - Risk-management-plan summary (PDF/340.06 KB)

Authorisation details

Product information

Adakveo : EPAR - Product information (PDF/1.36 MB)

Adakveo : EPAR - All authorised presentations (PDF/115.27 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Adakveo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/238.21 KB)

Adakveo Article-20 procedure - Annex - Scientific conclusions (PDF/182.79 KB)

Adakveo Article-20 procedure - Assessment report (PDF/2.57 MB)

Adakveo-H-C-PSUSA-00010888-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/178.29 KB)

Initial marketing-authorisation documents

Adakveo : EPAR - Public assessment report (PDF/7.2 MB)

Adakveo: Orphan maintenance assessment report (initial authorisation) (PDF/619.53 KB)

CHMP summary of positive opinion for Adakveo (PDF/206.65 KB)

News

Direct healthcare professional communications (DHPC)

More information on Adakveo

Related content

How useful was this page?