Sanofi secures US regulatory approval for new insulin pen

28 March 2018 (Last Updated March 28th, 2018 12:30)

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its new long-acting insulin pen, Toujeo Max SoloStar, for diabetes patients.

Sanofi secures US regulatory approval for new insulin pen
The new Max SoloStar pen holds 900 units of Toujeo, more than any other long-acting insulin pen in the US. Credit: Sanofi.

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its new long-acting insulin pen, Toujeo Max SoloStar, for diabetes patients.

Toujeo is 300units/ml of insulin glargine. The new high capacity device has the ability to hold 900 units of Toujeo and can dispense up to 160units/ml of the insulin glargine in one injection.

The company expects that Max SoloStar’s higher capacity will result in a decrease in the number of pens prescribed to adults for Toujeo use. This will lead to reduced refills and associated copays.

In certain patients, the maximum 160units/ml dose is expected to minimise the number of injections required to deliver the necessary Toujeo dosage.

“The new high capacity device has the ability to hold 900 units of Toujeo and can dispense up to 160units/ml of the insulin glargine in one injection.”

Sanofi North America Diabetes and Cardiovascular head Michelle Carnahan said: “This new high capacity pen has a broader range of doses than the original SoloStar, delivering Toujeo, long-acting insulin with established safety and efficacy.

“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.”

Toujeo Max SoloStar will be introduced in retail pharmacies across the US in the third quarter of 2018.

The company has decided to retain the price of Toujeo Max SoloStar’s predecessor SoloStar and provide a savings programme to make the new insulin pen variant financially accessible for patients.

Additionally, support will be provided through the free Toujeo COACH programme for adults using SoloStar or Max SoloStar.