FDA Approves New Maximum-Unit Insulin Pen

The US Food and Drug Administration (FDA) has approved glargine 300 units/mL insulin pen (Toujeo Max SoloStar) as the newest device for insulin injection therapy.

With the approval, the pen from Sanofi became the largest pen carrier of insulin units on the market — designed to hold 900 units/mL, and provide up to 160 units/mL per single injection.

The greater capacity of the Max SoloStar leads Sanofi to believe its newly-approved device could reduce the amount of pens adults prescribed to Toujeo use, thereby affecting their rate of refills and related copays. The maximum dosage rate may also reduce the number of necessary injections for some adults with diabetes.

The preceding SoloStar device for Toujeo injectios contained 450 units of insulin glargine, and a maximum single injection dose of 80 units/mL. At the time of its approval, Sanofi reported that this dosage met the “vast majority of patients on basal insulin in the US, who require 80 IU or less per day.”

Michelle Carnahan, North America Diabetes and Cardiovascular Head of Sanofi, highlighted the pen’s new capacity and dose range compared to the original SoloStar device.

“By reducing the number of injections for people who need more long-acting insulin and lowering copay costs — both of which are important to patients – Toujeo Max SoloStar underscores Sanofi's continued commitment to help those living with diabetes,” Carnahan said in a statement.

Toujeo, the once-daily long-acting basal insulin therapy, was approved by the FDA to treat glycemic control in adult patients with type 1 and type 2 diabetes in February 2015. In clinical trials included in its FDA application, the therapy was compared to 100 unit/mL once-daily insulin glargine injection (Lantus) in open-label, randomized, active-control studies that ran for 26 weeks, with a 6-month safety extension period.

According to Sanofi, its solution contains 3 times as much insulin in 1 mL as standard insulin therapies.

Max SoloStart will be available in US markets in the latter half of 2018. Sanofi expressed intention to make the new pen available at the same price as the original SoloStar device per unit, in order to accommodate patient costs.