Eli Lilly and Company today announced that the European Commission has granted marketing authorisation for Humalog® 200 units/ml KwikPen™ (insulin lispro 200 units/ml) for the treatment of diabetes in adults. Humalog 200 units/ml KwikPen is a prefilled pen that delivers the same amount of insulin in half the volume per injection as the currently marketed Humalog KwikPen (insulin lispro 100 units/ml).
The approval of Humalog 200 units/ml KwikPen provides patients and healthcare professionals with more options to meet their individual needs. It is intended for adults with diabetes who take more than 20 units of rapid-acting insulin per day. The prefilled pen contains 600 units of insulin – twice as many as Humalog KwikPen (insulin lispro 100 units/ml) – in the same 3 ml pen size, allowing people to use fewer pens.
"People with diabetes in the EU who require more than 20 units of mealtime insulin per day now have a new option to control their blood sugar levels," said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. "It represents an evolution in the mealtime insulin experience for patients who require such doses."
The Humalog 100 units/ml formulation has an established safety and efficacy profile. Approval of the Humalog 200 units/ml formulation was based on a demonstration of the bioequivalence of the Humalog 200 units/ml formulation to Humalog 100 units/ml formulation in a pharmacokinetic/pharmacodynamic clinical study.
Humalog 200 units/ml KwikPen received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on July 24, 2014.
"Diabetes is a progressive disease that requires unique options for individual patients. We are proud to continue with our commitment to supporting people living with diabetes," said Enrique Conterno, president of Lilly Diabetes.
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