Business & Finance
Sanofi wins US FDA approval for the expanded use of Soliqua 100/33 as add-on to diet and exercise for adults with type 2 diabetes
28 February 2019 -

Biopharmaceutical company Sanofi revealed on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 units/ml and 33 mcg/ml.

Soliqua 100/33, which was previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, can now be prescribed for patients uncontrolled on oral antidiabetic medicines, added the company.

According to the company, Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

This US FDA's approval, which was based on data from the company's LixiLan-O clinical trial in adults with type 2 diabetes uncontrolled with metformin and/or a second oral antidiabetic therapy, now showed that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide. In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 compared with insulin glargine or lixisenatide.

In conjunction, the company will continue offering its savings programme for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to USD0 for all commercially insured patients regardless of formulary status on an insurance plan or income level.