Sanofi submits new diabetes drug application to U.S. regulator
Published December 23, 2015
PARIS – French drugmaker Sanofi said on Wednesday it had submitted an application to the U.S. Food and Drug Administration (FDA) for a single daily insulin injection to treat adults with type 2 diabetes.
Sanofi said it had requested a six-month review of its new drug application by the FDA, rather than the standard 10 months.
"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," Sanofi's diabetes head, Pierre Chancel, said in a statement.
The latest application involves a combination of insulin glargine with its lixisenatide drug, Sanofi said.