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

News 23/05/2014

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An application for a change to the marketing authorisation for Protelos/Osseor has been withdrawn.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 medicineGazyvaro
International non-proprietary name (INN)obinutuzumab
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of chronic lymphocytic leukaemia
More information PDF iconSummary 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 information PDF iconSummary of opinion for Nuwiq

Name of medicinePlegridy
INNpeginterferon beta-1a
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment of relapsing remitting multiple sclerosis in adult patients
More information PDF iconSummary 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 information PDF iconSummary 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 information PDF iconSummary of opinion for Envarsus

Positive recommendations on new therapeutic indications

Name of medicineArzerra
INNofatumumab
Marketing-authorisation applicantGlaxo Group Ltd
More information PDF iconSummary of opinion for Arzerra

Name of medicineHalaven
INNeribulin
Marketing-authorisation applicantEisai Europe Ltd
More information PDF iconSummary of opinion for Halaven

Name of medicineVfend
INNvoriconazole
Marketing-authorisation applicantPfizer Ltd
More information PDF iconSummary of opinion for Vfend

Negative recommendation on new therapeutic indication

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation applicantRoche Registration Ltd
More information PDF iconQuestions 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 information PDF iconQuestions and answers on refusal of the marketing authorisation for Masiviera

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

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

Name of medicineTranslarna
INNataluren
Marketing-authorisation applicantPTC Therapeutics Limited
More information PDF iconSummary of opinion for Translarna
PDF iconQuestions 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 information PDF iconQuestions and answers on Protelos / Osseor

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOrganisational matters

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