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FDA Approves First-Ever Concentrated Mealtime Insulin

Twitter Summary: @Lilly_Diabetes gets @US_FDA approval for U200 KwikPen – first-ever concentrated mealtime insulin in US

Lilly just announced that the FDA has approved its Humalog 200 units/mL KwikPen (insulin lispro) for type 1 and type 2 diabetes, making it the first concentrated mealtime insulin analog to reach the US market. The pen has already been launched in Europe following its approval there last October. No pricing information for the KwikPen in the US is available at this time.

The new pen is the same size as the previous Humalog 100 units/mL KwikPen and holds the same volume (3 ml) of insulin. As we described in our previous coverage of its European approval, the key difference lies in the insulin strength (concentration). The new pen holds 600 total units of insulin, while the older pen only holds 300 total units. This concentrated form can add convenience by allowing patients to change insulin pens less frequently and reducing the amount of insulin (by volume) needed per injection.

For more information on insulin and injection pens, please see our resource pages here. -AJW