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.
Renalytix expands US clinical footprint with three kidneyintelX.dkd integrations
GSK wins European Commission approval for Shingrix prefilled syringe
Abbott launches Libre Assist for in-the-moment food decisions
RedHill advances RHB-102 across GI indications
FDA grants priority review for Sanofi's Tzield in young children with stage 2 type 1 diabetes
Samsung Bioepis begins direct commercialisation of BYOOVIZ in Europe
Diamyd Medical agrees accelerated efficacy readout in ongoing Phase 3 type 1 diabetes trial
Clywedog Therapeutics activates all clinical centres and patient dosing in balomenib Phase 1b study
Qlife's Egoo Health platform selected for major AI-driven diabetes and MASLD project in China
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Novo Nordisk reports strong phase 2 results for amycretin in type 2 diabetes
Innovent Biologics reports primary and all key secondary endpoints met in mazdutide Phase 3 trial
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Adocia files patent for long-acting peptide platform AdoXLong and updates on BioChaperone studies