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

  • Email
  • Help

News

23/05/2014

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An application for a change to the marketing authorisation for Protelos/Osseor has been withdrawn.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.

 

CHMP highlights May 2014

 

Positive recommendations on new medicines

Name of medicineGazyvaro
International non-proprietary name (INN)obinutuzumab
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of chronic lymphocytic leukaemia
More informationSummary of opinion for Gazyvaro
 Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia

 

Name of medicineNuwiq
INNsimoctocog alfa
Marketing-authorisation applicantOctapharma AB
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
More informationSummary of opinion for Nuwiq

 

Name of medicinePlegridy
INNpeginterferon beta-1a
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment of relapsing remitting multiple sclerosisin adult patients
More informationSummary of opinion for Plegridy

 

Name of medicineSimbrinza
INNbrinzolamide / brimonidine tartrate
Marketing-authorisation applicantAlcon Laboratories (UK) Ltd
Therapeutic indicationTreatment of open-angle glaucoma or ocular hypertension
More informationSummary of opinion for Simbrinza

 

Positive recommendation on new hybrid medicine 

Name of medicineEnvarsus
INNtacrolimus
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationProphylaxis and treatment of transplant / allograft rejection
More informationSummary of opinion for Envarsus

 

Positive recommendations on new therapeutic indications

Name of medicineArzerra
INNofatumumab
Marketing-authorisation applicantGlaxo Group Ltd 
More informationSummary of opinion for Arzerra

 

Name of medicineHalaven
INNeribulin
Marketing-authorisation applicantEisai Europe Ltd
More informationSummary of opinion for Halaven

  

Name of medicineVfend
INNvoriconazole
Marketing-authorisation applicantPfizer Ltd
More informationSummary of opinion for Vfend

  

Negative recommendation on new therapeutic indication

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation applicantRoche Registration Ltd
More informationQuestions and answers on refusal of the therapeutic indication for Avastin

 

Re-examinations of recommendations for new medicines

Name of medicineMasiviera
INNmasitinib
Marketing-authorisation applicantAB Science
More informationQuestions and answers on refusal of the marketing authorisation for Masiviera

 

Name of medicineNerventra
INNlaquinimod
Marketing-authorisation applicantTeva Pharma GmbH
More informationQuestions and answers on refusal of the marketing authorisation for Nerventra

 

Name of medicineReasanz
INNserelaxin
Marketing-authorisation applicantNovartis Europharm Ltd
More informationQuestions and answers on refusal of the marketing authorisation for Reasanz

 

Name of medicineTranslarna
INNataluren
Marketing-authorisation applicantPTC Therapeutics Limited
More informationSummary of opinion for Translarna
 Questions and answers on the positive opinion for the marketing authorisation for Translarna
 Press release: European Medicines Agency recommends first-in-class medicine for treatment of Duchenne muscular dystrophy

 

Public-health recommendation

Name of medicineRenin-angiotensin-system (RAS)-acting agents
More informationRenin-angiotensin-system (RAS)-acting agents

 

Outcome of arbitration procedure

Name of medicine Dexamed and associated names
More informationQuestions and answers on Dexamed and associated names

 

Outcome of harmonisation procedure

Name of medicine Seroquel / Seroquel XR and associated names
INNquetiapine
More informationQuestions and answers on Seroquel / Seroquel XR and associated names

 

Withdrawal of application for extension of therapeutic indication 

Name of medicineProtelos / Osseor
INNstrontium ranelate
Marketing-authorisation applicantLes Laboratoires Servier
More informationQuestions and answers on Protelos / Osseor

 

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
Organisational matters

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