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Eli Lilly Lyumjev secures the US FDA approval for type-1 and type-2 diabetes

FDA approved a novel formulation of insulin lispro, Lyumjev has been approved for adults. The drug is indicated to control blood sugar levels in type 1 and type 2 diabetes. It is a rapid-acting formulation designed for quick absorption of insulin after meals and a reduction in A1C levels.

The drug is available to both commercially insured, as well as to uninsured patients with a price cap of $35, based on Eli Lilly’s insulin affordability program. The price cap has also come in the wake of financial constraints faced due to coronavirus pandemic.

However, it is partially also based on widespread concern among the public over the gap in the affordability of insulin.

The approval was based on a randomized PRONTO-T1D and PRONTO-T2D trial. Lyumjev was compared versus Humalog. The primary endpoint was noninferiority in A1C reduction versus Humalog; at 26 weeks was met in both the studies. Whereas, it was superior to Humalog in lowering of blood glucose spike at both one hour and two hours after a test meal. Safety and tolerability profiles were similar in both the groups.

The drug is contraindicated in hypoglycemia or in patients with hypersensitivity to insulin lispro.

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