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FDA Approves Label Update for Semaglutide as a First-line Type 2 Diabetes Medication


The US Food and Drug Administration (FDA) recently approved a label update to permit an oral GLP-1 receptor agonist to be used as a first-line medication for adults with type 2 diabetes (T2D).

The label update for oral semaglutide (Rybelsus©, Novo Nordisk) removes a previous limitation that stated the medication should not be used as an initial therapy for people with T2D, according to a company press release. The update applies to the 7 mg and 14 mg tablets.

“The removal of the limitation of use is an important step forward for people living with type 2 diabetes and provides the option for Rybelsus© to be taken earlier,” said Aaron King, MD, family medicine and diabetes specialist, in the release. “By taking Rybelsus© first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilize this medicine early in their diabetes treatment journeys.”

The FDA approved oral semaglutide as the first noninjectable GLP-1 receptor agonist for the treatment of T2D in 2019. The approval came after findings from several large clinical trials of oral semaglutide that demonstrated superior HbA1c reductions vs placebo and against other common hyperglycemic agents, ie, empagliflozin and sitagliptin.

Oral semaglutide is comprised of a co-formulation of semaglutide and an absorption enhancer, sodium N-(8-[2-hydroxybenzoyl] amino) caprylate, which facilitates the absorption of semaglutide in the stomach, according to the manufacturer.

“In the US, hundreds of thousands of people with type 2 diabetes have been prescribed this medicine as part of their type 2 diabetes treatment regimen to help lower their A1c,” said Doug Langa, executive vice president of North America operations and president of Novo Nordisk, in the release. “As Novo Nordisk marks 100 years of commitment and innovation in diabetes care, Rybelsus© remains a pivotal part of our portfolio, making history as the first oral GLP-1 receptor agonist and helping to fuel our mission to improve the lives and health of people living with diabetes.”

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