The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, Sanofi said.
The fast-acting human insulin analog boosts glycemic control in adults and kids with diabetes mellitus.
Sanofi said that the FDA ruled that Admelog meets all necessary regulatory requirements for approval in the U.S., pending the resolution of any patent discrepancies.
“Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar,” Stefan Oelrich, SVP and head of Sanofi’s global diabetes franchise, said in prepared remarks. “With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin.”