Sanofi’s insulin injection Soliqua 100/33 now available in US

Soliqua 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection), made by Sanofi, is now available by prescription in US pharmacies.

It is indicated for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

"We are encouraged by the potential of Soliqua 100/33, which has demonstrated superior HbA1c lowering versus Lantus," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi.

"By offering a product containing both a basal insulin and a GLP-1 therapy – at a competitive price while facilitating patient access, we believe we are providing value to patients and the healthcare system."

Evidentiary support

In the clinical trial, once-daily Soliqua 100/33 demonstrated statistical superiority for the change in HbA1c from baseline to week 30 (p<0.0001) versus Lantus, the most prescribed basal insulin in the world.

Adverse effects

The most common side effects reported in the clinical program included low blood sugar, nausea, stuffy or runny nose and sore throat, diarrhoea, upper respiratory tract infection and headache.

Drug delivery

Soliqua 100/33 is delivered in a single pre-filled SoloStar pen with a dose range covering from 15 to 60 Units and two starting doses to support patients’ insulin needs.

Soliqua 100/33 was approved by the US Food and Drug Administration (FDA) on November 21, 2016.

Price

The daily Wholesale Acquisition Cost price of Soliqua 100/33 is $127 for a 300 Unit pen, which equals $19.90 per day at the average final dose of 47 Units used in the labelled clinical trial.

Sanofi is offering Soliqua 100/33 at a $0 co-pay for eligible US patients with commercial insurance and is working to secure coverage for Soliqua 100/33 on health plans nationwide. Sanofi is also offering a tailored support program, Soliqua 100/33 COACH, at no cost to adults living with type 2 diabetes who have been prescribed Soliqua 100/33 by their doctor.