US-FDA has approved Eli Lilly and Company's new ultra rapid-acting insulin Lyumjev™ (Insulin lispro-aabc injection) for type 1 and type 2 diabetes.
The US FDA granted approval to Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL). This is a new rapid fast-acting insulin with a novel formulation to speed up the absorption of insulin into the blood stream and reduce glucose levels post meals, mimicking natural insulin’s post prandial action. Eli Lilly has another fast-acting insulin Humalog™ in the market. In comparative studies, Lyumjev™ has demonstrated faster absorption profile compared to Humalog™. The rapid insulin time-action profile can be attributed to two excipients in the formulation: microdose of treprostinil which increases absorption through vasodilation and sodium citrate which increases local vascular permeability. The approval of the drug was based on two phase 3 studies: PRONTO T1D and PRONTO T2D. In both studies Lyumjev™ demonstrated superior action compared to Humalog in preventing blood glucose spikes one and two hours after meal. Earlier this year, the product was approved ...