It appears Sanofi will use a priority review voucher to catch up in the process to Novo Nordisk, which submitted an NDA for Xultophy in late September.
Sanofi announced today it has submitted a new drug application (NDA) to the FDA for its type 2 diabetes therapy that combines its mainstay insulin glargine Lantus with the GLP-1 receptor agonist lixisenatide. The combination is given once a day by injection.
The twist is Sanofi’s announcement that it will redeem a priority review voucher to designate the NDA for 6-month review instead of the customary 10 months. If the FDA accepts the application, Sanofi’s therapy could catch up to Novo Nordisk’s Xultophy, which combines Tresiba (insulin degludec) and the GLP-1 Victoza (liraglutide). Xultophy was approved in Europe in 2014, and Novo Nordisk filed an NDA for the therapy with FDA on September 29, 2015.
The Sanofi combination is a fixed-ratio combination of insulin glargine 100 units/mL plus lixisenatide. Lantus only recently came off patent, and Sanofi is now marketing Toujeo as its next generation long-acting insulin for adults with type 1 and type 2 diabetes. A commercial name for the new combination is under consideration, Sanofi said in a statement.
The announcement comes less than a month after Sanofi said FDA had accepted its NDA for lixisenatide as a monotherapy; that application was made after results of a cardiovascular outcomes trial, ELIXA, were presented to the American Diabetes Association in June.
“The NDA submission is a significant milestone in Sanofi’s efforts to further develop our insulin franchise,” said Pierre Chancel,” senior vice president, head of Global Diabetes at Sanofi. “A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medication or insulin.”
“We recognize the need for additional treatment options and look forward to working with the FDA during their consideration of our submission,” he said.
Sanofi’s application is based on data from the LixiLan-O and the LixiLan-L Phase III trials. Topline results from these trials, released in July and September, showed that among 1900 patients with uncontrolled diabetes, statistically significant declines in glycated hemoglobin (A1C) were achieved with the study combination therapy that had not been achieved with oral agents or insulin.