Eli Lilly recently announced that the US Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/ml and 200 units/ml), which is a new type of fast-acting mealtime insulin The product is suitable for improving blood sugar control in adults with type 1 and type 2 diabetes.
Lyumjev is a new, fast-acting preparation of insulin lispro, designed to accelerate the absorption of insulin into the blood and lower blood sugar levels. As a fast-acting mealtime insulin, Lyumjev controls the postprandial high blood sugar level of diabetic adult patients, similar to the way post-prandial insulin works in people without diabetes.
Previously, Lyumjev has been approved by multiple regulatory agencies worldwide, including Japan and the European Union in March 2020. Eli Lilly is currently working to provide Lyumjev to diabetes patients in the United States as soon as possible.
The approval is based on data from Phase III PRONTO-T1D and PRONTO-T2D studies. These two studies are randomized, positive drug control, and treatment compliance comparison. They were carried out in adult patients with type 1 and type 2 diabetes, respectively. Lyumjev and Humalog (Yumule, generic name: insulin lispro, insulin lispro, insulin lispro, 100 units/ Ml) were compared.
Both of these studies reached the primary end point: when taking a meal at mealtime, at the 26th week of treatment, Lyumjev's blood glucose (A1C) decrease from baseline was noninferior to Humalog. Multiple tests were performed on key endpoints, including a comparison of blood glucose at 1 hour and 2 hours after a meal. In these two studies, Lyumjev had significantly lower peak blood glucose levels at 1 and 2 hours after the meal compared to Humalog. In 2 studies, Lyumjev and Humalog had similar safety and tolerability.
Dr. Leonard Glass, Vice President of Medical Affairs at Eli Lilly, said: "We are proud to continue to work hard in the long tradition of developing new insulin. Lyumjev is an important new treatment to help control postprandial blood glucose levels. For diabetics, Postprandial blood glucose control may be a challenge, and Lyumjev’s approval underscores our commitment to meeting their needs.”