- According to a source close to the matter, Sanofi (SNY +2.2%) intends to launch its long-acting insulin, Toujeo (insulin glargine 300 IU/mL), in the U.S. on Monday, which is consistent with its earlier statement that it planned to launch at the beginning of Q2.
- Toujeo, approved by the FDA on February 25, is a once-daily injection of basal insulin that has three times more insulin per mL than its top-selling Lantus (insulin glargine [rDNA origin] 100 IU/mL).
- Sanofi will have the long-acting insulin market to itself for a while. Novo Nordisk (NVO +0.9%) plans to resubmit its NDA for its offering, Tresiba (insulin degludec), shortly, but approval won't happen until next year at the earliest. Eli Lilly (LLY +0.2%) postponed its NDA for basal insulin peglispro until "after 2016" so it can assess its effects on the liver.
- Previously: Novo Nordisk trys again with Tresiba and Ryzodeg NDA resubmission to FDA (March 26)
- Previously: Side effect of Lilly basal insulin potentially delays regulatory filings past 2016 (Feb. 23)