Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019
EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions of indication at its first meeting in Amsterdam in March 2019.
The Committee recommended granting a conditional marketing authorisation for Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene), an advanced therapy medicinal product (ATMP) for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo is intended for adult and adolescent patients 12 years and older who need regular blood transfusions to manage their disease and have no matching donor for a stem cell transplant.
Since Zynteglo addresses an unmet medical need, it benefited from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. This interaction led to a more robust application package which allowed accelerated assessment of Zynteglo in 150 days, the fastest review time for an ATMP to date. Zynteglo was designated as an orphan1 medicine during its development.
For more information, please see the press release in the grid below.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Imnovid, Mozobil and Revlimid.
Outcome of re-examination of recommendation on omega-3 fatty acid medicines
The CHMP confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack. This is the outcome of a re-examination requested by some of the companies that market the medicines concerned, following the Committee’s original recommendation in December 2018.
For more information, please see the public health recommendation in the grid below.
Agenda and minutes
The agenda of the March 2019 meeting is published on EMA's website. Minutes of the February 2019 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the March 2019 CHMP meeting are represented in the graphic below.
1 As always at time of approval, this orphan designation will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
| Name of medicine | Zynteglo |
|---|---|
| International non-proprietary name (INN) | Autologous CD34+ cells encoding βA-T87Q-globin gene |
| Marketing-authorisation applicant | bluebird bio (Netherlands) B.V. |
| Therapeutic indication | Treatment of transfusion-dependent β-thalassaemia |
| More information | Press release: New gene therapy to treat rare inherited blood condition |
| Name of medicine | Imnovid |
|---|---|
| INN | pomalidomide |
| Marketing-authorisation holder | Celgene Europe BV |
| Name of medicine | Mozobil |
|---|---|
| INN | plerixafor |
| Marketing-authorisation holder | Genzyme Europe BV |
| Name of medicine | Revlimid |
|---|---|
| INN | lenalidomide |
| Marketing-authorisation holder | Celgene Europe BV |
| Name of medicine | Omega-3 fatty acid medicines |
|---|---|
| INN | omega-3 fatty acid medicines |
| More information | EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack |
| Name of medicine | Septanest and associated names |
|---|---|
| INN | articaine (hydrochloride) /adrenaline (tartare) |
| More information |
| Name of medicine | Basiron AC |
|---|---|
| INN | benzoyl peroxide |
| More information | Change not granted to the marketing authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU |
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Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 March 2019 (PDF/129.84 KB)
First published: 04/04/2019
EMA/101446/2019 -
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Scientific advice and protocol assistance adopted during the CHMP meeting 25 - 28 March 2019 (PDF/118.49 KB)
Adopted
First published: 29/03/2019
EMA/CHMP/SAWP/196240/2019 -
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Overview of (invented) names reviewed in February 2019 by the Name Review Group (NRG) adopted at the CHMP meeting of 25-28 March 2019 (PDF/81.77 KB)
Adopted
First published: 29/03/2019
EMA/195285/2019
Related content
- Adenuric: EPAR
- Imnovid (previously Pomalidomide Celgene): EPAR
- Mozobil: EPAR
- Revlimid: EPAR
- Zynteglo: EPAR
- Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction: Article 31 referrals
- Septanest and associated names: Article 30 referrals