FDA Updates Label for Oral Semaglutide, Making Agent a First-Line Therapy in Type 2 Diabetes


Announced by Novo Nordisk on January 12, the label update from the FDA removes a previous indication stating oral semaglutide (Rybelsus) should not be used as an initial therapy, which clears the way for the agent to be used as a first-line therapy in type 2 diabetes.

FDA logo in black over a white background

The US Food and Drug Administration (FDA) has approved a label update for oral semaglutide (Rybelsus) allowing the agent to be used as first-line therapy in adults with type 2 diabetes.

The updated label, which was announced by Novo Nordisk on January 12 and includes both the 7 mg and 14 mg formulations of oral semaglutide, removes a previous limitation stating the medication should not be used as an initial therapy, clearing the way for the oral GLP-1 receptor agonist to be used a first-line therapy in adults with type 2 diabetes.

“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. “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.”

In September 2019, oral semaglutide became the first and only oral GLP-1 analog to receive approval from the US FDA, with this approval based on the results of the pivotal PIONEER program. In the program, oral semaglutide was compared in a head-to-head fashion against other antihyperglycemic agents, including sitagliptin, empagliflozin, and liraglutide in a population of more than 9500 people with type 2 diabetes.

Following initial approval in September 2019, which indicated the agent as an adjunct diet and exercise to improve glucose in type 2 diabetes for those not achieving their HbA1c goals, the FDA approved a label update in January 2020 to indicate the agent for reducing risk of major adverse cardiovascular events based on results of the PIONEER 6 trial. In the statement announcing the label update indicating oral semaglutide as a first-line option for type 2 diabetes, Novo Nordisk noted oral semaglutide had been prescribed to more than 100,000 people with type 2 diabetes since approval in September 2019.

“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, North America operations and president of Novo Nordisk. “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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