CSII - FDA OKs expanded labelling or Lilly's Lyumjev 100 units/ml in insulin pumps

The FDA has approved an expanded label for Eli Lilly's (NYSE:LLY) rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion with an insulin pump. The approval was based on results from Phase 3 PRONTO-PUMP-2 study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog. Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared to Humalog. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

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FDA OKs expanded labelling or Lilly's Lyumjev 100 units/ml in insulin pumps