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

News 25/04/2014

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applications for marketing authorisation for Ditelos/Issarlos and for an extension of indication for Votrient have been withdrawn.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.

Positive recommendation on new medicine

Name of medicine	Mekinist
International non-proprietary name (INN)	trametinib
Marketing-authorisation applicant	Glaxo Group Ltd
Therapeutic indication	Treatment of unresectable or metastatic melanoma with a BRAF V600 mutation
More information	Summary 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 medicine	Gardasil
INN	human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Marketing-authorisation applicant	Sanofi Pasteur MSD, SNC
More information	Summary of opinion for Gardasil

Name of medicine	Gilenya
INN	fingolimod
Marketing-authorisation applicant	Novartis Europharm Ltd
More information	Summary of opinion for Gilenya

Name of medicine	Invega
INN	paliperidone
Marketing-authorisation applicant	Janssen-Cilag International N.V.
More information	Summary of opinion for Invega

Name of medicine	Nexavar
INN	sorafenib
Marketing-authorisation applicant	Bayer Pharma AG
More information	Summary of opinion for Nexavar
	Press release: European Medicines Agency recommends extending use of Nexavar to include treatment of differentiated thyroid cancer

Name of medicine	Pradaxa
INN	dabigatran etexilate
Marketing-authorisation applicant	Boehringer Ingelheim International GmbH
More information	Summary of opinion for Pradaxa

Name of medicine	Prolia
INN	denosumab
Marketing-authorisation applicant	Amgen Europe B.V.
More information	Summary of opinion for Prolia

Name of medicine	Silgard
INN	human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
More information	Summary 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 medicine	Caustinerf arsenical and Yranicid arsenical
INN	lidocaine, ephedrine, arsenic trioxide
More information	Caustinerf arsenical and Yranicid arsenical

Re-examination of public-health recommendation

Name of medicine	Estradiol (topical use)
More information	Estradiol (topical use)

Withdrawals of applications

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