FDA approves Humalog 200 units/mL KwikPen (U200)(insulin Lispro) for types 1 & 2 diabetes-Eli Lilly

Eli Lilly and Company has announced that the FDA has approved Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge. This offers patients a pen that lasts longer between pen changes, allowing for fewer changes every month. Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.

Comment: Adocia and Eli Lilly had an earlier agreement for a BioChaperone version of Humalog that was abandoned in 2011 after Eli Lilly decided to focus its attention elsewhere. Adocia continued with the project independently and trials reported that BioChaperone lispro exhibited a significantly faster onset of action compared to Humalog.

Eli Lilly licensed the rights to the drug from Adocia. Potential benefits of BioChaperone lispro include greater flexibility in the timing of insulin injections, lower variability of post-meal blood glucose elevations, lower rates of hypoglycaemia and better overall glucose control.

Humalog 200 units/mL KwikPen (U 200) was approved in the EU in October 2014.