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An application for a change to the marketing authorisation for Protelos/Osseor has been withdrawn.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