At its June 2013 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 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.
The CHMP recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars, Remsima and Inflectra are in the same indications as Remicade (infliximab), a monoclonal antibody that has been authorized in the European Union (EU) since 1999.
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 authorization 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.
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 authorization 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.
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 also adopted a final negative opinion following the re-examination of Labazenit.
The CHMP recommended an extension of the existing indication for Eylea, Evicel, Onglyza, Velcade and Zonegran.