Summary of recent progress in the field of diabetes research (04.04) April 04, 2018 Source: WuXi PharmaTech 1. New drug type 1 diabetes sotagliflozin submitted marketing application in Europe Recently, Sanofi announced that the European Medicines Agency (EMA) has accepted a regulatory review application for its new diabetes drug sotagliflozin. If approved, the drug will be used as a supplement to insulin therapy to improve glycemic control in patients with type 1 diabetes. Sotagliflozin is a drug developed by Sanofi in collaboration with Lexicon Pharmaceuticals, a partner of WuXi PharmaTech, an oral dual inhibitor targeting sodium-glucose cotransporters type 1 and 2 (SGLT1 & SGLT2) responsible for glucose regulation. . SGLT1 is responsible for glucose absorption in the gastrointestinal tract, while SGLT2 is responsible for glucose reabsorption in the kidney. In clinical studies, sotagliflozin has been shown to be effective in improving glycemic control in patients with type 1 diabetes while reducing the need for insulin at mealtimes. The application to the EMA was based on data from the inTandem clinical trial, which consisted of three Phase 3 clinical trials evaluating the safety and efficacy of sotagliflozin in approximately 3,000 adult patients with type 1 diabetes. The results of the trial showed that after 24 weeks of oral gotagliflozin, the patient's blood glucose level was in the target blood glucose range (70-180 mg/dL) with a statistically significant increase compared with the placebo group. Moreover, sotagliflozin is well tolerated. "Type 1 diabetes management, although progressing in recent years, is still a challenge that has prevented many patients from meeting their treatment goals. In addition to supplementing insulin, other therapies are needed to help people with type 1 diabetes better control their blood sugar levels. Sotagliflozin is The first dual inhibitor of SGLT1 and SGLT2 that has reached regulatory review steps in Europe,†said Dr. Jorge Insuasty, Senior Vice President, Global Development, Sanofi. “We look forward to working with EMA to complete the review process and bring this potential to patients. Therapy." 2. Maximum capacity long-acting insulin can be listed in the US Recently, the US FDA approved Sanofi's Toujeo MaxSoloStar for adult patients with diabetes. Toujeo MaxSoloStar is the longest-acting insulin pen with the largest capacity on the market. According to the statistics of the International Diabetes Federation, more than 100 million people in China have diabetes. By 2040, the number is expected to grow to more than 150 million, and medical needs are huge. Many people with diabetes need insulin supplements to help the body regulate blood sugar levels. Toujeo is a long-acting insulin injection (300 mg/ml of insulin glargine) once daily for controlling blood sugar levels in adult diabetic patients. The new Toujeo MaxSoloStar pen has 900 units of insulin, which is higher than any other long-acting insulin pen on the market in the United States, and can provide up to 160 units/ml of Toujeo in a single injection. Due to its larger capacity, MaxSoloStar may reduce the number of refills and associated costs, and the maximum single injection dose of up to 160 units/ml may also reduce the number of injections required for certain adult diabetics to reach the dose. Toujeo MaxSoloStar will be launched throughout the United States in the third quarter of 2018. “The new high-capacity pen MaxSoloStar has a wider dose range than the original SoloStar and provides long-acting insulin Toujeo in a safe and effective manner,†said Ms. Michelle Carnahan, Sanofi's North American Diabetes and Cardiovascular Director. The number of times and the reduction in drug prices, two important points for patients, Toujeo MaxSoloStar confirmed Sanofi's continued commitment to helping people with diabetes." 3. New drug for diabetes, sotagliflozin, submits a new drug application to the US FDA Recently, Lexicon Pharmaceuticals announced that its collaborator Sanofi has submitted a new drug application (NDA) to the US FDA for sotagliflozin and submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for This new drug is used in combination with insulin to improve glycemic control in adult patients with type 1 diabetes. Sotagliflozin is a drug developed by Lexicon Pharmaceuticals in collaboration with Sanofi. It is an oral dual inhibitor that targets the sodium-glucose cotransporter type 1 and 2 (SGLT1 & SGLT2) responsible for glucose regulation. SGLT1 is responsible for glucose absorption in the gastrointestinal tract, while SGLT2 is responsible for glucose reabsorption in the kidney. In clinical studies, sotagliflozin has been shown to be effective in improving glycemic control in patients with type 1 diabetes while reducing the need for insulin at mealtimes. "In the United States, approximately three-quarters of adult patients with type 1 diabetes do not meet their glycosylated hemoglobin (A1C) goals, so sotagliflozin will be an important advance in the treatment of these patients," University of Southern California (USC) professor, USC clinical Dr. Anne Peters, Director of the Diabetes Program and Chairman of the Sotagliflozin Type 1 Diabetes Steering Committee, said: "It is likely to be the first oral drug in the United States to be used in conjunction with insulin to improve glycemic control and patient outcomes." “Sotagliflozin's NDA and MAA submission represents an important milestone for Lexicon and type 1 diabetes in Europe and the United States,†said Dr. Pablo Lapuerta, Executive Vice President and Chief Medical Officer of Lexicon Pharmaceuticals. “These applications highlight our in-house R&D therapy. Strong investment and the culmination of the largest phase 3 clinical study in the widest range of patients with type 1 diabetes, we have the most comprehensive database of efficacy and safety. I am very proud of our team members, they don't know Tired towards this goal, in order to bring this important potential therapy to patients with type 1 diabetes." Reference materials: [1] Sanofi: EMA to review sotagliflozin as potential treatment for type 1 diabetes [2] FDA approves Toujeo® Max SoloStar® [3] Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults With Type 1 Diabetes Original Title: Summary of Recent Progress in Diabetes Research (No. 54) Home AIDS are items we can't live without in our daily lives. They can help us take better care of our health and that of our families. Here are some common home AIDS: Home measuring instrument,necessities of life,AIDS are used in the home TRUTECH CO., LTD. , https://www.trutechealth.com
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