Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 24-27 June 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 24-27 June 2013
This page provides an overview of the opinions adopted at the June 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
In one of the busiest CHMP meetings of 2013 so far, the Committee recommended ten new medicines for approval, including the first two monoclonal antibody biosimilars, and a new advanced therapy medicine. These medicines are intended for patients suffering from diseases including cancer, multiple sclerosis and other auto-immune diseases.
Ten new medicines recommended for approval
The CHMP recommended granting of marketing authorisations for the first two monoclonal antibody biosimilars.Remsima and Inflectra are recommended for authorisation in the same indications as Remicade (infliximab), a monoclonal antibody that has been authorised in the European Union (EU) since 1999. For more information, please see press release in the table below.
Three medicines to treat cancer received positive opinions from the CHMP: Provenge, a cell-based therapy for the treatment of metastatic castrate-resistant prostate cancer, which is also the fourth advanced therapy medicinal product to be recommended for marketing authorisation by the CHMP; Tafinlar, for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation; and Stivarga for the treatment of metastatic colorectal cancer. Please see press releases on Provenge and Tafinlar in the table below.
The CHMP gave positive recommendations for the approval of Procysbi for the management of cystinosis andLemtrada for the treatment of multiple sclerosis.
The Committee also recommended the granting of a marketing authorisation for Cholib as adjunctive therapy to diet and exercise, to reduce triglycerides and increase HDL-cholesterol levels in adults with mixed dyslipidaemia with high cardiovascular risk, Nexium Control for the short-term treatment of reflux symptoms in adults, andEvarrest for the treatment of haemostasis, and as an adjunct to haemostasis.
Re-examination of two initial recommendations for marketing authorisation
The CHMP adopted a positive re-examination opinion for Aubagio, revising its previous opinion not to grant new active substance status to the medicine at its March 2013 meeting.
The CHMP adopted a final negative opinion following the re-examination of Labazenit.
Five recommendations for extensions of indications
The CHMP recommended an extension of the existing indication for Eylea, Evicel, Onglyza, Velcade andZonegran.
Outcome of two safety reviews
The Committee also issued recommendations on ergot derivatives-containing products and iron-containing IV products.
Question-and-answer documents on the withdrawal of marketing authorisation applications for Ixinity andOmontys are published below.
More information on these and all other outcomes of the CHMP June 2013 meeting is available on the Agency's website at:
Contact our press officers
Monika Benstetter or Martin Harvey Allchurch
Tel. +44 (0)20 7418 8427