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April 29, 2019 /Bio Valley BIOON/--French pharmaceutical giant Sanofi (Sanofi) and its partner Lexicon Pharmaceuticals have recently jointly announced that the European Commission (EC) has approved Zynquista (sotagliflozin) as a Insulin adjuvant drugs for adult patients with type 1 diabetes (T1D) who have a body mass index ≥27kg/m2 and cannot achieve adequate blood sugar control after receiving the best insulin therapy. Zynquista is administered orally in doses of 200 mg and 400 mg once a day.
In the United States, Zynquista was rejected by the FDA in late March because of the increased risk of diabetic ketoacidosis (DKA) when Zynquista was combined with insulin compared with insulin alone.
The European Commission approved Zynquista based on data from the inTandem clinical project, which included 3 phase III clinical studies, enrolling about 3000 adult T1D patients with poorly controlled blood glucose levels to evaluate the efficacy and safety of Zynquista. The results showed that all three studies reached the primary endpoint. Compared with insulin alone, the two doses of Zynquista (200mg and 400mg) were used as an oral adjuvant for insulin to achieve a continuous and significant reduction in mean blood glucose level (HbA1c), body weight, and systolic blood pressure from baseline to the 24th week of treatment. The time in the target blood glucose range is significantly extended. This was achieved without the usual increase in severe hypoglycemia caused by insulin intensification, and there were fewer severe hypoglycemia events at the 400 mg dose at 52 weeks.
Consistent with selective SGLT-2 inhibitors, Zynquista's clinical trials have shown an increased risk of genital fungal infection and diabetic ketoacidosis (DKA), which is thought to affect T1D patients more frequently than type 2 diabetes (T2D). Several leaders in the diabetes science community believe that through appropriate patient selection, education, and ketone monitoring, the risk of DKA associated with SGLT inhibitors can be controlled. By carefully selecting patients for Zynquista treatment, and through risk management plans and mitigation strategies, the risk of DKA can be addressed. Action strategies that include educational activities for patients, medical professionals, and caregivers will support its safe use.
Sotagliflozin molecular structure
Thomas Danne, Professor of Pediatrics at the Children’s Hospital of Hannover, Germany, commented: “There are millions of patients with type 1 diabetes in Europe, even with the best insulin therapy, it is difficult to control their blood sugar. For many overweight or obese patients with type 1 diabetes, Zynquista will provide a With the new treatment plan, European doctors can now consider combining it with insulin therapy for suitable patients."
Dr. John Reed, head of Sanofi’s global research and development, said, “Zynquista’s dual mechanism of action provides important therapeutic benefits for adults with type 1 diabetes, including reducing blood glucose reabsorption in the kidney by inhibiting SGLT2, and inhibiting intestinal SGLT1 delays the absorption of sugar in the diet."
The active pharmaceutical ingredient of Zynquista is sotagliflozin, which is a dual-acting inhibitor of SGLT-1/SGLT-2, which is being developed for the treatment of type 1 diabetes and type 2 diabetes. SGLT is called sodium-glucose cotransporter and has two types. SGLT-1 is mainly responsible for the absorption of glucose in the gastrointestinal tract, and SGLT-2 is mainly responsible for the reabsorption of glucose by the kidneys. In addition to T1D, Zynquista's treatment of type 2 diabetes (T2D) is already in phase III clinical trials. The project has a total of 11 clinical studies, including 2 studies in type 2 diabetes patients with renal impairment, and 2 large-scale cardiac Vascular outcome study.
At present, SGLT2 inhibitors have achieved great success in the treatment of T2D treatment. There are many SGLT-2 inhibitors on the market, including canagliflozin, dapagliflozin, enpagliflozin and so on. Some pharmaceutical companies are also developing SGLT-2 inhibitors for the treatment of type 1 diabetes. In December 2018, Astellas Suglat (ipragliflozin L-proline) was approved by Japan to treat type 1 diabetes. In March of this year, AstraZeneca's Forxiga (andatone, dapagliflozin) was approved by the European Union and Japan to treat type 1 diabetes. (Bioon.com)
Original source: ZYNQUISTA™ NOW APPROVED IN THE EUROPEAN UNION FOR TREATMENT OF ADULTS WITH TYPE 1 DIABETES
