Eli Lilly's Lyumjev (insulin lispro-aabc injection) Receives the US FDA's Expanded Label Approval for the Treatment of Type 1 and Type 2 Diabetes
- The approval is based on P-III PRONTO-PUMP-2- a treat-to-target study that evaluates the efficacy & safety of Lyumjev (insulin lispro-aabc injection- 100 units/mL) vs Humalog (insulin lispro injection- 100 units/mL) in 432 adults in a ratio (1:1) with T1D for 16wks.
- The study met its 1EPs i.e.- non-inferior A1C reduction from baseline @16wks. Lyumjev demonstrated a superior reduction in blood glucose spikes at 1hr. & 2hrs. after a test meal
- Lyumjev is also approved in Japan & EU. Additionally- the Lilly insulin value program is available for patients with commercial insurance or no insurance along with a Seniors Savings model for people in a Medicare Part D program
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