Sanofi announced that the US Food and Drug Administration (FDA) granted tentative approval for Admelog (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the US, 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.
With the tentative approval, the FDA concluded that Admelog met all necessary regulatory requirements for approval in the U.S., pending any patent issues that are yet to be resolved.
"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," said Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."
The trade name "Admelog" was granted provisional approval by the FDA and will be used in the U.S. when the product is made available. Admelog was also granted marketing authorization under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017.