Updated on 1 July 2013
EMA gives marketing approval for mAb, cancer drugs
Singapore: Europe Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorizations for monoclonal antibody biosimilars, Remsima and Inflectra.
Also, 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.