EMA - 10 nových molekul k registraci

18.07.2013 10:41

The Committee for Medicinal Products for Human Use recommended 10 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 (European Medical Agency = EMA) 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 and Lemtrada 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, and Evarrest 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.

Four recommendations for extensions of indications

The CHMP recommended an extension of the existing indication for Evicel, Onglyza, Tyverb and Velcade.


This page provides an overview of the opinions adopted at the June 2013 (24-27 June 2013) meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.




Převzato: www.ema.europa.eu