With competition on the horizon for moneyspinner Lantus, Sanofi is looking to its new insulin glargine formulation to protect its diabetes franchise. The new depot version of the long-acting insulin, codenamed U300, is the subject of a raft of phase III trials aimed at securing US approval, as well as proving that it can hold its own against current and future competition.
U300’s destiny will be decided when the Edition trials read out over the coming months. Phase II trials showed a much flatter glycaemia curve than that seen with its predecessor, and the new formulation will have to make good on this by reducing the incidence of nocturnal hypoglycaemia. It will also have to prove its cardiovascular safety if it is to avoid the same fate as Tresiba (Dizzy day for Novo as FDA rejects Tresiba, February 11, 2013).