Sanofi Seeks Approval for Once-Daily Type 2 Diabetes Treatment
Sanofi has submitted a new drug application to the FDA for a fixed-ratio combination of insulin glargine and lixisenatide.
Sanofi has submitted a new drug application (NDA) to the FDA for a fixed-ratio combination of insulin glargine and lixisenatide.
The formula, which includes 100 units/mL of insulin glargine, is designed to be administered as a once-daily injection to treat patients with type 2 diabetes.
The NDA included data from 2 phase 3 studies, LixiLan-O and LixiLan-L, which both demonstrated positive results earlier in 2015.
These studies examined the safety and efficacy of the formula in more than 1900 patients, however the treatment has not yet been evaluated by any regulatory authority yet.
"This NDA submission is a significant milestone in Sanofi's efforts to further develop our insulin franchise," said Pierre Chancel, senior vice president and head of Global Diabetes at Sanofi, in a press release. "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 medications or insulin. We recognize the need for additional treatment options and look forward to working with the FDA during their consideration of our submission."
The formula’s proprietary name has not yet been determined, Sanofi wrote in a press release.