FDA Grants Tentative Approval to Insulin Lispro Injection

September 1, 2017

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The drug, produced by Sanofi, was granted approval based on the physiochemical, non-clinical, and clinical similarity to another, already approved insulin lispro injection.

The US Food and Drug Administration (FDA) has granted tentative approval to insulin lispro 100 Units/mL injection (Admelog), a rapid-acting human insulin analog, for the improvement of glycemic control in adults and children with diabetes mellitus.

The drug, produced by Sanofi, was granted approval based on the physiochemical, non-clinical, and clinical similarity to another, already approved insulin lispro 100 Units/mL injection, according to a Sanofi statement.

Data from a clinical development program that included more than 1000 adults with type 1 and type 2 diabetes was also considered in the decision.

The FDA concluded that the insulin lispro injection met all regulatory requirements for approval in the US, however, the approval was granted tentatively pending any possible patent issues that are currently being resolved.

"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," Stefan Oelrich, the senior vice president and head of the Global Diabetes Franchise at Sanofi, said in a statement. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."

According to Sanofi, the drug is “contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients.”

The drug’s trade name, Admelog, was granted provisional approval by the FDA for use in the US when the product becomes available. It was granted authorization for the name Insulin lispro Sanofi by the European Commission in July 2017.