The first oral drug for type 2 diabetes belonging to the class of GLP-1 agonists, developed by Novo Nordisk, has got the go-ahead from the FDA.
The Danish company is known for its blockbuster injectable drug in the same class — liraglutide — that is now one of the most highly prescribed drugs in the world. However, it has taken the company 10 years to get an oral glucagon-like peptide-1 (GLP-1) agonist on the market.
Branded as Rybelsus, the drug is an oral form of semaglutide, a type 2 diabetes drug from Novo Nordisk. Semaglutide was approved in 2017 as a GLP-1 agonist injected weekly rather than daily like liraglutide. Although oral semaglutide needs to be given daily instead of once per week, patients will be able to take the medication without the discomfort of an injection.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” stated Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
Semaglutide acts like the hormone GLP-1, an incretin hormone involved in controlling blood sugar levels. The drug helps to reduce blood sugar by increasing insulin levels and decreasing levels of the hormone glucagon. Additionally, it can reduce appetite and slow digestion, helping patients to lose weight.
The drug was approved based on phase III trials in over 9,500 type 2 diabetes patients. According to these trials, Rybelsus was more effective at controlling blood glucose than approved oral drugs, sitagliptin and empagliflozin, as well as the injected GLP-1 agonist liraglutide. The drug also reduced patients’ body weight by up to 4 kg.
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