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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 ...
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.
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 [1] [4] The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022.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]
Sweden's drugs agency on Monday asked doctors to hold off on prescribing diabetes drugs for the treatment of obesity, pointing to signs that a spike in such usage has left diabetics short of ...
[15] [16] Because the drug was the first GLP-1 agonist that could be taken once a day, sales projections in 2013 were €500M per year by 2018. [16] Sanofi resubmitted the application which the FDA accepted in September 2015, by which time Sanofi had lost the lead in the field of anti-diabetic drugs to Novo Nordisk. [17]
The most common side effects include urinary infections, nasopharyngitis, and upper respiratory tract infections . [5] [6] The most serious side effects include ketoacidosis (high blood levels of acids called ‘ketoacids’), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels).
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