Novo Nordisk announces label expansion for Rybelsus

Courtesy of Getty Images

The FDA approved Novo Nordisk’s Rybelsus (semaglutide) as a first-line treatment option for adults with type 2 diabetes, signaling a shift from its previous indication as a second-line approach.

This move makes Rybelsus the first oral GLP-1 receptor agonist to gain FDA approval as a first-line treatment for type 2 diabetes. In using the drug as an initial therapy, along with diet and exercise, to improve glycemic control, company representatives said they hope the approval may interrupt disease progression.

By taking Rybelsus first, people with type 2 diabetes, along with their physicians and lifestyles, stand to take an “important step forward,” said Aaron King, M.D., a diabetes specialist and Novo Nordisk advocate.

Use in Obesity

Though the approval marks a potentially appealing treatment option for adults with diabetes, providers who treat obesity are also optimistic about the drug’s potential to assist in weight loss.

According to a report published by Reuters, some controversy exists over whether oral applications like Rybelsus could be a first-line treatment for obesity as well, citing its importance in this space merits the same attention as diabetes.

On Monday, the American Academy of Pediatrics (AAP) recommended the use of weight-loss drugs in children aged 12 and older, affecting 14.4 million young people in the U.S., alone.

Other medicines, like metformin, have been used off-label previously to assist in weight loss with success.

This new guideline put out by the AAP, also marks a shift in philosophy, as the first treatment (versus prevention) option in a decade for childhood obesity.

"I think they are important because there are a number of misunderstandings about exactly what causes obesity and there are some unintended biases, even by medical providers with regard to childhood obesity," said Marc Michalsky, M.D. of Nationwide Children's Hospital, a co-author of the guidelines to Reuters.

Going Forward

As diabetes is linked as a co-morbid condition with obesity, the approval of Rybelsus stands to affect more than just its current indication in diabetes as a stand-alone condition.