Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2014

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

Six new medicines recommended for approval

This month the CHMP recommended marketing authorisation for Gazyvaro (obinutuzumab) for the treatment of chronic lymphocytic leukaemia. Gazyvaro has an orphan designation. Please see the press release in the grid below for more information.

The CHMP also recommended granting a conditional marketing authorisation for Translarna (ataluren), an orphan-designated medicine for the treatment of Duchenne muscular dystrophy. This followed a re-examination of the Committee's earlier negative opinion. For more information, please see the press release in the grid below.

The Committee recommended approval for Plegridy (peginterferon beta-1a) for the treatment of relapsing remitting multiple sclerosis in adults.

The CHMP also gave a positive recommendation for Nuwiq (simoctogog alfa) for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Simbrinza (brinzolamide / brimonidine tartrate) has also been recommended for marketing authorisation for the treatment of open-angle glaucoma or ocular hypertension.

The hybrid medicine Envarsus (tacrolimus), for the prophylaxis and treatment of transplant/allograft rejection, was recommended for marketing authorisation by the Committee.

Three recommendations on extensions of indications

The CHMP recommended extensions of indications for Arzerra, Halaven and Vfend.

Re-examination procedures concluded

In addition to the re-examination procedure for Translarna (see above), the CHMP concluded three further re-examination procedures, issuing final negative opinions for Masiviera, Nerventra and Reasanz.

Outcome of safety review

The CHMP has confirmed restrictions on the use of medicines that act on the renin-angiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body.

Withdrawal of application

An application for a change to the marketing authorisation for Protelos/Osseor has been withdrawn. A question-and-answer document on the withdrawal is available below.

Agenda and minutes

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

CHMP statistics

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

Positive recommendations on new medicines

Name of medicine	Gazyvaro
International non-proprietary name (INN)	obinutuzumab
Marketing-authorisation applicant	Roche Registration Ltd
Therapeutic indication	Treatment of chronic lymphocytic leukaemia
More information	CHMP summary of positive opinion for Gazyvaro
	Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia

Name of medicine	Nuwiq
INN	simoctocog alfa
Marketing-authorisation applicant	Octapharma AB
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
More information	CHMP summary of positive opinion for Nuwiq

Name of medicine	Plegridy
INN	peginterferon beta-1a
Marketing-authorisation applicant	Biogen Idec Ltd
Therapeutic indication	Treatment of relapsing remitting multiple sclerosis in adult patients
More information	CHMP summary of positive opinion for Plegridy

Name of medicine	Simbrinza
INN	brinzolamide / brimonidine tartrate
Marketing-authorisation applicant	Alcon Laboratories (UK) Ltd
Therapeutic indication	Treatment of open-angle glaucoma or ocular hypertension
More information	CHMP summary of positive opinion for Simbrinza

Positive recommendation on new hybrid medicine

Name of medicine	Envarsus
INN	tacrolimus
Marketing-authorisation applicant	Chiesi Farmaceutici S.p.A.
Therapeutic indication	Prophylaxis and treatment of transplant / allograft rejection
More information	CHMP summary of positive opinion for Envarsus

Positive recommendations on new therapeutic indications

Name of medicine	Arzerra
INN	ofatumumab
Marketing-authorisation applicant	Glaxo Group Ltd
More information

Name of medicine	Halaven
INN	eribulin
Marketing-authorisation applicant	Eisai Europe Ltd
More information	CHMP post-authorisation summary of positive opinion for Halaven

Name of medicine	Vfend
INN	voriconazole
Marketing-authorisation applicant	Pfizer Ltd
More information	CHMP post-authorisation summary of positive opinion for Vfend

Negative recommendation on new therapeutic indication

Name of medicine	Avastin
INN	bevacizumab
Marketing-authorisation applicant	Roche Registration Ltd
More information	Questions and answers on the refusal of a change to the marketing authorisation for Avastin (bevacizumab)

Re-examinations of recommendations for new medicines

Name of medicine	Masiviera
INN	masitinib
Marketing-authorisation applicant	AB Science
More information	Questions and answers on refusal of the marketing authorisation for Masiviera

Name of medicine	Nerventra
INN	laquinimod
Marketing-authorisation applicant	Teva Pharma GmbH
More information	Questions and answers on refusal of the marketing authorisation for Nerventra

Name of medicine	Reasanz
INN	serelaxin
Marketing-authorisation applicant	Novartis Europharm Ltd
More information	Questions and answers on refusal of the marketing authorisation for Reasanz

Name of medicine	Translarna
INN	ataluren
Marketing-authorisation applicant	PTC Therapeutics Limited
More information	CHMP summary of positive opinion for Translarna
	Questions and answers on the positive opinion on the marketing authorisation for Translarna (ataluren)
	Press release: European Medicines Agency recommends first-in-class medicine for treatment of Duchenne muscular dystrophy

Public-health recommendation

Name of medicine	Renin-angiotensin-system (RAS)-acting agents
More information	Renin-angiotensin-system (RAS)-acting agents

Outcome of arbitration procedure

Name of medicine	Dexamed and associated names
More information	Questions and answers on Dexamed and associated names

Outcome of harmonisation procedure

Name of medicine	Seroquel / Seroquel XR and associated names
INN	quetiapine
More information	Questions and answers on Seroquel / Seroquel XR and associated names

Withdrawal of application for extension of therapeutic indication

Name of medicine	Protelos / Osseor
INN	strontium ranelate
Marketing-authorisation applicant	Les Laboratoires Servier
More information	Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Protelos (strontium ranelate)