Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Specialty Devices
Diabetes Care Devices
Return to: MDBR Home | Specialty Devices | Diabetes Care Devices

Sanofi gets FDA approval for Toujeo Max SoloStar insulin pen device

MDBR Staff Writer Published 28 March 2018

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its new insulin pen device, Toujeo (insulin glargine 300units/mL) Max SoloStar.

The new Max SoloStar pen accommodates 900 units of Toujeo, and can deliver up to 160units/mL of Toujeo in a single injection.

Its higher capacity will help to reduce the number of pens adults prescribed Toujeo use, allowing for fewer refills and related copays.

The maximum dose of up to 160units/mL will also allow to reduce the number of injections needed to deliver the required Toujeo dosage for some diabetes patients.

Sanofi is planning to launch the Toujeo Max SoloStar in retail pharmacies across the US in the third quarter of this year.

Toujeo is a long-acting insulin developed to control blood sugar in adults with diabetes mellitus. It contains three times more insulin in 1mL compared to standard insulin (100units/mL).

Toujeo cannot be used for the treatment of diabetic ketoacidosis, and should be avoided to treat children.

According to Sanofi, Toujeo SoloStar and Toujeo Max SoloStar are disposable prefilled insulin pens, and required to carry out a safety test when using a new pen for the first time.

Toujeo should not be diluted or mixed with any other insulin or solution, which will result in drop of blood sugar control and not work as intended. It should be used only if the solution is clear and colorless with no particles visible.

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, a 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."


Image: Sanofi’s Toujeo Max SoloStar insulin pen device. Photo: courtesy of PRNewsfoto / Sanofi.