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FDA: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [40] provides recommendations for the development of drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Specifically, this guidance ...
Teplizumab, sold under the brand name Tzield, is a humanized anti-CD3 monoclonal antibody that is the first approved treatment indicated to delay the onset of stage 3 type 1 diabetes in people with stage 2 type 1 diabetes. [3] [4] [5] The Fc region of this antibody has been engineered to have Fc receptor non-binding (FNB) properties. [6]
Drugs used in diabetes treat types of diabetes mellitus by decreasing glucose levels in the blood. With the exception of insulin , most GLP-1 receptor agonists ( liraglutide , exenatide , and others), and pramlintide , all diabetes medications are administered orally and are thus called oral hypoglycemic agents or oral antihyperglycemic agents.
Pramlintide has been approved on 3/16/2005 by the FDA, for use by type 1 and type 2 diabetic patients who use insulin. [6] (subscription required) Pramlintide allows patients to use less insulin, lowers average blood sugar levels, and substantially reduces what otherwise would be a large unhealthy rise in blood sugar that occurs in diabetics right after eating.
Sotagliflozin was approved for medical use in the European Union in April 2019, as Zynquista, for the treatment for type 1 diabetes, [2] and in the United States in May 2023, [3] to reduce the risk of death due to heart failure. [1] [4] The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022. [2]
It was approved for use in the European Union in May 2015, [5] for use in the United States in August 2015, [6] and for use in Australia in May 2020. [2] In 2020, it was the 238th most commonly prescribed medication in the United States, with more than 1 million prescriptions. [7] [8] It is available as a generic medication. [9]
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