Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

29 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 ?^A-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.

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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.

Positive recommendation on new medicine

Name of medicine	Zynteglo
International non-proprietary name (INN)	Autologous CD34+ cells encoding ?A-T87Q-globin gene
Marketing-authorisation applicant	bluebird bio (Netherlands) B.V.
Therapeutic indication	Treatment of transfusion-dependent ?-thalassaemia
More information	Press release: New gene therapy to treat rare inherited blood condition

CHMP summary of positive opinion for Zynteglo

AdoptedReference Number: EMA/CHMP/166977/2019

Positive recommendations on extensions of indications

Name of medicine	Imnovid
INN	pomalidomide
Marketing-authorisation holder	Celgene Europe BV

CHMP post-authorisation summary of positive opinion for Imnovid (II-31-G)

AdoptedReference Number: EMA/CHMP/177804/2019

 

Name of medicine	Mozobil
INN	plerixafor
Marketing-authorisation holder	Genzyme Europe BV

CHMP post-authorisation summary of positive opinion for Mozobil (II-34)

AdoptedReference Number: EMA/CHMP/198032/2019

 

Name of medicine	Revlimid
INN	lenalidomide
Marketing-authorisation holder	Celgene Europe BV

CHMP post-authorisation summary of positive opinion for Revlimid (II-102-G)

AdoptedReference Number: EMA/CHMP/195079/2019

Outcome of re-examination of public-health recommendation

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

Outcome of harmonisation procedure

Name of medicine	Septanest and associated names
INN	articaine (hydrochloride) /adrenaline (tartare)
More information	Use of Septanest and associated names (articaine / adrenaline solutions for injection) to be harmonised in EU

Outcome of arbitration procedure

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

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 March 2019

Reference Number: EMA/101446/2019

Scientific advice and protocol assistance adopted during the CHMP meeting 25 - 28 March 2019

AdoptedReference Number: EMA/CHMP/SAWP/196240/2019

Overview of (invented) names reviewed in February 2019 by the Name Review Group (NRG) adopted at the CHMP meeting of 25-28 March 2019

AdoptedReference Number: EMA/195285/2019