Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2014
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.
Three recommendations on extensions of indications
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An application for a change to the marketing authorisation for Protelos/Osseor has been withdrawn.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.
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||Summary of opinion for Gazyvaro|
|Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia|
|Name of medicine||Nuwiq|
|Marketing-authorisation applicant||Octapharma AB|
|Therapeutic indication||Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)|
|More information||Summary of opinion for Nuwiq|
|Name of medicine||Plegridy|
|Marketing-authorisation applicant||Biogen Idec Ltd|
|Therapeutic indication||Treatment of relapsing remitting multiple sclerosis in adult patients|
|More information||Summary of 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||Summary of opinion for Simbrinza|
Positive recommendation on new hybrid medicine
|Name of medicine||Envarsus|
|Marketing-authorisation applicant||Chiesi Farmaceutici S.p.A.|
|Therapeutic indication||Prophylaxis and treatment of transplant / allograft rejection|
|More information||Summary of opinion for Envarsus|
Positive recommendations on new therapeutic indications
|Name of medicine||Arzerra|
|Marketing-authorisation applicant||Glaxo Group Ltd|
|More information||Summary of opinion for Arzerra|
|Name of medicine||Halaven|
|Marketing-authorisation applicant||Eisai Europe Ltd|
|More information||Summary of opinion for Halaven|
|Name of medicine||Vfend|
|Marketing-authorisation applicant||Pfizer Ltd|
|More information||Summary of opinion for Vfend|
Negative recommendation on new therapeutic indication
|Name of medicine||Avastin|
|Marketing-authorisation applicant||Roche Registration Ltd|
|More information||Questions and answers on refusal of the therapeutic indication for Avastin|
Re-examinations of recommendations for new medicines
|Name of medicine||Masiviera|
|Marketing-authorisation applicant||AB Science|
|More information||Questions and answers on refusal of the marketing authorisation for Masiviera|
|Name of medicine||Nerventra|
|Marketing-authorisation applicant||Teva Pharma GmbH|
|More information||Questions and answers on refusal of the marketing authorisation for Nerventra|
|Name of medicine||Reasanz|
|Marketing-authorisation applicant||Novartis Europharm Ltd|
|More information||Questions and answers on refusal of the marketing authorisation for Reasanz|
|Name of medicine||Translarna|
|Marketing-authorisation applicant||PTC Therapeutics Limited|
|More information||Summary 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|
|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|
|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|
|Marketing-authorisation applicant||Les Laboratoires Servier|
|More information||Questions and answers on Protelos / Osseor|