New drugs approved

by Gary Finnegan – EMA Highlights – The EMA has given its backing to a number of medicines including:

–         Tresiba from Novo Nordisk (insulin degludec), a new basal analogue insulin for the treatment of diabetes mellitus in adults. The product comes in a pre-filled pen in two formulations: 100 units/ml and 200 units/ml. This is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, for many years the only strength of insulin available across the EU.

–         Zaltrap, 25 mg/ml, concentrate for solution for infusion, intended, in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, for the treatment of adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. The active ingredient in Zaltrap, by Sanofi-Aventis is aflibercept, an antineoplastic agent acting as a decoy receptor of Vascular Endothelial Growth Factor (VEGF) thereby blocking the VEGF biological pathway. This pathway is important for the blood supply of tumours, although other biological functions of the pathway have been described.

–         Lyxumia, 10 µg, 20 µg and 10 µg/20 µg, solution for injection, intended for the treatment of type 2 diabetes. The active substance of Lyxumia is lixisenatide, a Glucagon-like peptide 1 (GLP-1) analogue medicinal product. Like native GLP-1, lixisenatide stimulates insulin release from the pancreatic islets, suppresses glucagon secretion, delays gastric emptying, and reduces body weight.