Global health care company Sanofi, which operates a division dedicated to the development of diabetes therapies, recently forwarded a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide.
"This NDA submission is a significant milestone in Sanofi's efforts to further develop our insulin franchise," Pierre Chancel, head of Sanofi's global diabetes division, said. "A large unmet medical need still exists for people with type II diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin."
The new therapy was tested earlier this year in a study involving 1,900 patients across the world. Testing yielded positive top-line results.
The new therapy is being given priority review by the FDA, which means it will be reviewed within six months, four months sooner than typical applications.
"We recognize the need for additional treatment options and look forward to working with the FDA during their consideration of our submission," Chancel said.
Should the FDA approve the application, the new therapy would be marketed as a once-daily injection.
