Zynquista (Sotagliflozin), the First Oral SGLT-1/2 Dual Inhibitor, Approved in the EU as Adjunct to Insulin for Adults with Type 1 Diabetes
Sanofi
Pharmaceutical R&D Developer
Lexicon Pharmaceuticals
Pharmaceutical R&D Developer
European Union
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2019Year04Month29Day/BioValleyBIOON/--French pharmaceutical giant Sanofi (Sanofi) and partnersLexiconPharmaceutical companies recently jointly announced that the European Commission (EC) ApprovedZynquista（sotagliflozin, Sotagliflozin), as an adjunct to insulin, for use in patients with a body mass index ≥27kg/m2and who still fail to achieve adequate glycemic control despite receiving optimal insulin therapy1Type diabetes (T1D) Adult patients.ZynquistaAdministered orally, once daily200mgand400mg。
In the United States,ZynquistaYu3in late month wasFDARejection of approval, with the reason being: compared to insulin monotherapy,ZynquistaDiabetic Ketoacidosis During Combined Insulin Therapy (DKA) increased risk.
European Commission ApprovalZynquista, is based oninTandemData from the clinical project, which includes3GeIIIPhase clinical study, with a total enrollment of approximately3000of poorly controlled blood glucose levelsT1DAdult patients, assessedZynquistaefficacy and safety. The results showed that this3All studies achieved the primary endpoint. Compared with insulin monotherapy,2DoseZynquista（200mgand400mg) as an oral adjunct to insulin therapy, both reduce mean blood glucose levels (HbA1c), body weight, and systolic blood pressure from baseline to treatment week24Weekly reductions were sustained and significant, with a marked increase in the time patients spent within the target glucose range. This was achieved without the usual increase in severe hypoglycemia associated with intensive insulin therapy.52Weekly400mgFewer severe hypoglycemic events at this dose.
SelectivitySGLT-2consistent with the inhibitor,Zynquistaof clinical trials showed genital fungal infections and diabetic ketoacidosis (DKA) increased risk, which is considered to be more than2Type diabetes (T2D) more frequently affectsT1DPatients. Several leaders in the diabetology community believe that, through appropriate patient selection, education, and ketone monitoring, it is possible to controlSGLTInhibitor-relatedDKARisk. Through careful patient selection forZynquistaTreatment, and through risk management plans and mitigation strategies, can be addressedDKArisks. Action strategies, including educational programs for patients, healthcare professionals, and caregivers, will support its safe use.
sotagliflozinMolecular Structural Formula
Professor of Pediatrics, Hannover Children's Hospital, GermanyThomas DanneComments stated: "There are millions in Europe1Patients with type 2 diabetes mellitus often struggle to achieve glycemic control even with optimal insulin therapy. For many overweight or obese1patients with type diabetes,Zynquista“It will provide a new treatment option that European physicians can now consider in combination with insulin therapy for appropriate patients.”
Head of Global R&D, SanofiJohn ReedThe doctor stated, “Zynquista's dual mechanism of action for patients with1offers important therapeutic benefits to adults with type diabetes, including through the inhibition ofSGLT2Reduce glucose reabsorption in the kidneys, and by inhibiting intestinalSGLT1Delaying sugar absorption from diet.”
ZynquistaThe active pharmaceutical ingredient issotagliflozin, this is aSGLT-1/SGLT-2Dual-acting inhibitor, currently under development for1Type diabetes and2Treatment of Type Diabetes.SGLTNamed Sodium-Sodium-glucose cotransporter, with2Types,SGLT-1Primarily responsible for the absorption of glucose in the gastrointestinal tract,SGLT-2Primarily responsible for renal glucose reabsorption. ExceptT1DIn addition,ZynquistaTreatment2Type 2 diabetes (T2D) is already inIIIPhase clinical trial, the project has a total of11a clinical study, including those with renal impairment2conducted in patients with type diabetes2study, and2A Large-Scale Cardiovascular Outcomes Study.
Currently,SGLT2Inhibitors in the treatmentT2DTremendous success has been achieved in treatment, with multiple products already available on the marketSGLT-2Inhibitors, including canagliflozin, dapagliflozin, and empagliflozin. Some pharmaceutical companies are also developingSGLT-2Inhibitors are used for1Treatment of Type 2 Diabetes.2018Year12June, AstellasSuglat（ipragliflozin L-proline, IpragliflozinL-Proline) approved in Japan for treatment1Type diabetes. This year3Month, AstraZenecaForxiga(Forxiga, dapagliflozin) approved by the EU and Japan for treatment1Type 2 Diabetes. (BioValleyBioon.com）
Original Source:ZYNQUISTA™ NOW APPROVED IN THE EUROPEAN UNION FOR TREATMENT OF ADULTS WITH TYPE 1 DIABETES