Pharma Focus America

FDA Approves Label Update for Novel Type 2 Diabetes Drug

Friday, February 10, 2023

The FDA has authorized a label update for Novo Nordisk Rybelsus® (semaglutide), allowing the medication to be administered in addition to diet and exercise as a first-line treatment, to improve glycemic control in individuals with type 2 diabetes.

The modified label, which covers both the oral semaglutide 7 mg and 14 mg forms, removes a previous warning that the drug shouldn't be used as the first line of treatment for those with type 2 diabetes.

Rybelsus®, which received initial FDA approval in 2019, is the first and only glucagon-like peptide-1 (GLP-1) analogue in pill form.

In contrast to other oral diabetic medications, Rybelsus® lowers blood sugar in three different ways: by raising the pancreatic release of insulin when blood sugar is high, by reducing the liver's release of sugar, and by delaying the exit of food from the stomach after eating.

Rybelsus is a new medication that combines semaglutide and the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). Semaglutide is more easily absorbed in the stomach because of these components, which makes it possible to administer it as a pill.

Nausea, stomach (abdominal) pain, diarrhoea, decreased appetite, vomiting, and constipation are some of the most common side effects of RYBELSUS®. When you start taking RYBELSUS®, nausea, vomiting, and diarrhoea are most frequently experienced.

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