US Food and Drug Administration (FDA) has approved Eli Lilly and Company 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) Humalog U-200 KwikPen is used to improve glycemic control in people with type 1 and type 2 diabetes.
Diabetes, often referred to by doctors as diabetes mellitus, describes a group of metabolic diseases in which the person has high blood glucose (blood sugar), either because insulin production is inadequate, or because the body's cells do not respond properly to insulin, or both.Humalog U-200 KwikPen represents a new option for people with diabetes. 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. The most common side effect of Humalog is hypoglycemia (low blood sugar) that may be severe and cause unconsciousness, seizures and death.
Approval was based on a demonstration of the bioequivalence of Humalog 200 units/mL relative to Humalog 100 units/mL in a pharmacokinetic/ pharmacodynamic study. The U.S. approval follows the approval of Humalog 200 units/ml KwikPen in the European Union on October 3, 2014.
Subscribe to PharmaTutor News Alerts by Email >>
