Adakveo
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
Review of sickle cell disease medicine Adakveo started
EMA has started a review of Adakveo, a medicine for preventing painful crises (called vaso-occlusive pain crises) in patients with sickle cell disease.
The review was prompted by preliminary results from an ongoing study in patients with sickle cell disease which indicate that, after one year of treatment, Adakveo did not reduce the number of painful crises leading to a healthcare visit compared with placebo (a dummy treatment). The study, called the STAND study, looks at the effectiveness and safety of Adakveo compared with placebo in adolescents and adults who had previously had painful crises leading to a healthcare visit. Data from this study were requested by EMA as part of the conditions to the marketing authorisation.
EMA will review these findings in the context of all available data and assess their impact on the benefit-risk balance of Adakveo in its approved indication. The Agency will then recommend whether the medicine’s marketing authorisation should be amended.
A letter will be sent in due course to relevant healthcare professionals to inform them of these preliminary results and the ongoing review. The letter will also be published on the EMA website.
Key facts
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About this medicine
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|
|---|---|
| Approved name |
Adakveo
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| International non-proprietary name (INN) or common name |
crizanlizumab
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| Associated names |
Adakveo
|
| Class |
Other haematological agents
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About this procedure
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|---|---|
| Current status |
Procedure started
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| Reference number |
EMEA/H/A-20/1525/C/4874/0013
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| Type |
Article 20 procedures
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues. |
| Authorisation model |
Centrally authorised product(s)
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| Decision making model |
CHMP-EC
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Key dates and outcomes
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|---|
All documents
Procedure started
Adakveo Article-20 procedure - Notification (PDF/37.43 KB)
First published: 27/01/2023
Adakveo Article-20 procedure - CHMP List of questions (PDF/92.28 KB)
First published: 27/01/2023
EMA/CHMP/37456/2023
Adakveo Article-20 procedure - Timetable for the procedure (PDF/85.42 KB)
First published: 27/01/2023
EMA/CHMP/36788/2023
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.