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.
Bavarian Nordic secures new EU contract for up to 8 million smallpox and mpox vaccine doses
Perrigo to pay quarterly dividend of USD0.290 per share
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Nanoform and Revio Therapeutics partner to develop long-acting hydrogel therapy for glioma
Cumberland Pharmaceuticals adds FDA-approved oral capsule for H. pylori to commercial portfolio
IP Group positions for future royalties following Pfizer's USD7.3bn acquisition of Metsera
AstraZeneca strikes landmark drug pricing deal with US Government
Fusion Antibodies secures multi-target humanisation contract with global pharmaceutical client
Genmab to acquire Merus in USD8bn deal to strengthen oncology pipeline