Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2014

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25/04/2014

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2014

This page provides an overview of the opinions adopted at the April 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

One new medicine recommended for approval

The CHMP has recommended granting a marketing authorisation for Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Mekinist is the first cancer treatment that selectively targets the MEK protein kinase. Please see the press release in the grid below for more information.

Seven recommendations on extensions of therapeutic indications

The CHMP has recommended adding a new indication to the use of the cancer medicine Nexavar (sorafenib) to treat progressive, locally advanced or metastatic, differentiated thyroid cancer. Please see the press release in the grid below for more information.

The Committee also recommended extensions of indications for Gilenya, Invega, Pradaxa, Prolia, Gardasil and Silgard.

Review of adrenaline auto-injectors started

The CHMP has started a review of adrenaline auto-injectors, which are used as first-aid treatment of anaphylaxis. This review was requested by the United Kingdom (UK) medicines agency following a national review of all adrenaline auto-injector products approved in the UK.

Outcome of safety review

The CHMP recommended that the marketing authorisations for the dental pastes Caustinerf arsenical, Yranicid arsenical and associated names be revoked in the European Union due to concerns over the risk of genotoxic effects and cell death in tissues around the teeth.

Outcome of re-examination of high-dose estradiol

The CHMP has updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.

Withdrawals of applications

The applications for marketing authorisation for Ditelos/Issarlos and for an extension of indication for Votrient have been withdrawn. Please see question-and-answer documents in the grid below.

Update on Herceptin, Alimta and Remicade

The CHMP discussed the recent theft of vials of the anticancer medicine Herceptin 150 mg. The vials, after being stolen in Italy, were tampered with and re-introduced under false credentials into the supply chain in some countries. The Committee agreed upon a direct communication to alert healthcare professionals in concerned Member States.

A document listing the batches of Herceptin (trastuzumab), Alimta (pemetrexed) and Remicade (infliximab) that are the subject of ongoing investigations into the theft of vials of these medicines in Italy, as announced by the EMA on 16 and 17 April, has been published on the EMA website. The list of batches is based on the latest information available. It will continue to be updated as the situation evolves.

Agenda and minutes

The agenda of the April 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the May CHMP meeting. Minutes of the March 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the April 2014 CHMP meeting are represented in the graphic below.

 CHMP highlights April

 

Positive recommendation on new medicine

Name of medicineMekinist
International non-proprietary name (INN)trametinib
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of unresectable or metastatic melanoma with a BRAF V600 mutation
More informationSummary of opinion for Mekinist
 Press release: European Medicines Agency recommends approval of Mekinist for the treatment of melanoma

 

Positive recommendations on extensions of therapeutic indications

Name of medicineGardasil
INNhuman papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Marketing-authorisation applicantSanofi Pasteur MSD, SNC
More informationSummary of opinion for Gardasil

 

Name of medicineGilenya
INNfingolimod
Marketing-authorisation applicantNovartis Europharm Ltd
More informationSummary of opinion for Gilenya

 

Name of medicineInvega
INNpaliperidone
Marketing-authorisation applicantJanssen-Cilag International N.V.
More informationSummary of opinion for Invega

 

Name of medicineNexavar
INNsorafenib
Marketing-authorisation applicantBayer Pharma AG
More informationSummary of opinion for Nexavar
 Press release: European Medicines Agency recommends extending use of Nexavar to include treatment of differentiated thyroid cancer

 

Name of medicinePradaxa
INNdabigatran etexilate
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
More informationSummary of opinion for Pradaxa

  

Name of medicineProlia
INNdenosumab
Marketing-authorisation applicantAmgen Europe B.V.
More informationSummary of opinion for Prolia

 

Name of medicineSilgard
INNhuman papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Marketing-authorisation applicantMerck Sharp & Dohme Limited
More informationSummary of opinion for Silgard

 

Start of referral

Name of medicine Adrenaline auto injectors
More information Adrenaline auto injectors Article-31 referral

 

Public-health recommendation

Name of medicineCaustinerf arsenical and Yranicid arsenical
INNlidocaine, ephedrine, arsenic trioxide
More informationCaustinerf arsenical and Yranicid arsenical

 

Re-examination of public-health recommendation

Name of medicineEstradiol (topical use)
More informationEstradiol (topical use)

 

Withdrawals of applications

Name of medicineDitelos / Issarlos
INN strontium ranelate / cholecalciferol
Marketing-authorisation applicant Les Laboratoires Servier
More informationQuestions and answers on Ditelos / Issarlos

 

Name of medicineVotrient
INNpazopanib
Marketing-authorisation applicantGlaxo Group Ltd
More informationQuestions and answers on Votrient

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in March 2013 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu