The U.S. Food and Drug Administration approved Eli Lilly and Co.'s Lyumjev, a rapid-acting insulin injection.
The drug — insulin lispro-aabc injection, available in 100 units/milliliter and 200 units/milliliter — controls high blood sugar levels in adult patients with diabetes.
The approval was based on data from phase 3 trials called Pronto-T1D and Pronto-T2D, which showed Lyumjev was better than the company's other insulin product, Humalog, at reducing spikes in blood glucose one hour and two hours after meals.
Regulators in the EU and Japan approved Lyumjev in March. Indianapolis-based Eli Lilly said it is working to make the treatment available in the U.S. as soon as possible.
Lyumjev will be included in the Lilly Insulin Value Program, allowing for a monthly prescription of the therapy for $35, the company added.