Novo Nordisk wins FDA’s approval for first oral GLP-1 treatment for type 2 diabetes

The U.S. Food and Drug Administration approved on Friday Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.

FDA pointed out that Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes, FDA said.

Novo Nordisk said in its press release that the approval of Rybelsus is based on the results from 10 PIONEER clinical trials which included 9,543 adults with type 2 diabetes.

Novo Nordisk highlighted that Rybelsus more effectively lowered blood sugar than sitagliptin and empagliflozin. Furthermore, treatment with Rybelsus resulted in up to 4.4 kg reduction in body weight. Also, Rybelsus showed a safe and well-tolerated profile across the PIONEER programme, with the most common adverse event being mild to moderate nausea which diminished over time.

This meant the first oral GLP-1 available in the US and thereby expand the treatment options for adults living with type 2 diabetes, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.