FDA accepts filing for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for diabetes-Novo Nordisk

Novo Nordisk have announced that the FDA has accepted for review the Class II Resubmissions for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review, on matters related to the interim analysis. As previously communicated, the result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations.

Comments; Tresiba was intended to compete with Lantus (insulin glargine), the best-seller from Sanofi, but its entry to the US market was delayed some years by the FDA. Tresiba has advantages over Lantus as it has a longer half life and less hypoglycaemia. In the meantime Sanofi now has US approval for Toujeo (basal insulin), a longer acting successor to Lantus. Eli Lilly and Boehringer have filed LY 2963016 (now Basaglar in the US and Abasaglar in the EU), a cost-cutting biosimilar version of Lantus which has tentative US approval but is subject to litigation brought by Sanofi defending its Lantus patent rights.