Tentative FDA approval of Admelog, a follow-on insulin lispro injection

The US Food and Drug Administration on Friday granted tentative approval for Admelog (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analogue from French pharma major Sanofi (Euronext: SAN).

A follow-on insulin lispro injection, Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus. News of the FDA decision lifted Sanofi’s shares 1.3% to 82.71 euros on Friday.

The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the USA, ie, Eli Lilly’s (NYSE: LLY) Humalog, including data from a clinical development program involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients.