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Novo Nordisk’s type 2 diabetes drug approved by FDA as first-line option

Rybelsus was initially approved in 2019 as a second-line treatment

Novo Nordisk

Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a label update for Rybelsus (oral semaglutide), which is now indicated as a first-line treatment option for adults with type 2 diabetes.

The update removes a previous limitation of use that stated that the drug should not be used as the initial therapy.

Initially approved by in the US in 2019, Rybelsus is the first and only analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1) in pill form and is indicated, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.

Rybelsus works differently to other diabetes pills to lower blood sugar by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver, and slowing the process of food leaving the stomach after eating.

Dr Aaron King, family medicine and diabetes specialist, said: "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.

"By taking Rybelsus first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilise this medicine early in their diabetes treatment journeys.”

The FDA’s 2019 decision on Rybelsus was based on the results from ten PIONEER clinical trials, which included 9,543 adults with type 2 diabetes.

In the programme, Rybelsus was shown to more effectively lower blood sugar than sitagliptin and empagliflozin, and treatment with Rybelsus also resulted in up to 4.4kg reduction in body weight.

Rybelsus demonstrated a safe and well-tolerated profile across the programme, the company reported, with the most common adverse event being mild-to-moderate nausea, which diminished over time.

Doug Langa, executive vice president, North America operations and president of Novo Nordisk, said: "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.

“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."

Article by
Emily Kimber

17th January 2023

From: Regulatory



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