The Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection; Lilly) to improve glycemic control in adults with type 1 and type 2 diabetes.
Lyumjev is a novel formulation of insulin lispro designed to rapidly reduce glucose levels after meals. It is administered at the start of a meal or within 20 minutes after starting a meal. According to pharmacokinetic data, following subcutaneous injection, insulin lispro-aabc appeared in circulation approximately 1 minute after injection. Time to 50% maximum and maximum insulin lispro-aabc concentration was observed to be 13 and 57 minutes, respectively.
The approval was based on data from the two, 26-week, randomized, active-controlled phase 3 studies (PRONTO-T1D and PRONTO-T2D) that compared the efficacy and safety of Lyumjev to Humalog® (insulin lispro injection; Lilly) in adults with type 1 and type 2 diabetes, respectively.
Results from both studies showed that Lyumjev was found to be noninferior to Humalog with regard to HbA1c reduction from baseline to week 26 (primary end point). Additionally, Lyumjev was found to be superior to Humalog in controlling 1- and 2-hour postprandial glucose excursions in patients with type 1 and type 2 diabetes.
The safety profile of Lyumjev was similar to that seen with Humalog. The most common adverse reactions with Lyumjev included hypoglycemia, injection site reactions, allergic reactions, rash, pruritus, lipodystrophy, and weight gain.
Lilly announced that it will offer a copay savings card for Lyumjev to assist eligible patients as part of its Insulin Value Program. The list price of Lyumjev will be the same as that of Humalog.
Lyumjev will be available as 100 Units/mL of insulin lispro-aabc in 10mL multiple-dose vials and 3mL single-use cartridges, KwikPens, Junior KwikPens, and TempoPens. The product will also be supplied as 200 Units/mL of insulin lispro-aabc in 3mL single-use KwikPens.
For more information visit lyumjev.com.