FDA approves label update for semaglutide as a first-line type 2 diabetes medication
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The FDA has 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, according to a company press release.
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 type 2 diabetes. 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,” Aaron King, MD, a family medicine and diabetes specialist, said 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.”
As Healio previously reported, the FDA approved oral semaglutide as the first noninjectable GLP-1 receptor agonist for the treatment of type 2 diabetes in 2019. The approval came after findings from a series of trials revealed the medication conferred superior HbA1c reductions compared with placebo, an oral SGLT2 inhibitor and an oral DPP-IV inhibitor. The medication 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.
“In the U.S., 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 HbA1c,” Doug Langa, executive vice president of North America operations and president of Novo Nordisk, said 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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