Sanofi announced yesterday that the FDA has accepted its New Drug Application (NDA) for Toujeo, a U300 formulation of insulin glargine. The company anticipates an FDA decision in the first half of 2015; assuming that the NDA was filed roughly two months ago (as per PDUFA V), that guidance appears consistent with a ~12-month review cycle from filing until possible approval. This announcement follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) on May 27. The NDA for Toujeo is based on results from the global EDITION phase 3 program, which found that Toujeo had equal A1c-lowering efficacy compared to Lantus (insulin glargine U100) – see our coverage of EDITION III at ADA. Although Sanofi pointed to slight weight and hypoglycemia benefits in some of the EDITION trials, these benefits were not seen across the board. There has been some concern about whether the hypoglycemia data from the EDITION studies will be robust enough to convince regulators that Toujeo has a clinically meaningful hypoglycemia benefit, particularly given the FDA’s hard stance against Novo Nordisk’s hypoglycemia claims for Tresiba (insulin degludec); we believe the improvements will be quite meaningful for some patients, particularly on the stability front, and expect strong patient advocacy at FDA given what happened with Novo Nordisk’s degludec, which has been seen quite negatively by a slew of patient advocates (including diaTribe). See our report on Sanofi’s ADA investor call for management commentary on Toujeo. If approved, Toujeo would likely be the first “second-gen” insulin glargine formulation on the US or European market, as the timeline for Lilly’s new insulin glargine formulation has been delayed by a Sanofi lawsuit and Merck/Samsung Bioepis’ insulin glargine formulation only recently entered phase 3. Overseas, of course, Toujeo face off against novel basal insulins including Novo Nordisk’s Tresiba (degludec) and perhaps Lilly’s novel liver-selective basal insulin.