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FDA Approves First Oral GLP-1 RA

FDA Approves First Oral GLP-1 RA

The US Food and Drug Administration has approved semaglutide (Rybelsus, Novo Nordisk) as the first oral glucagon-like peptide receptor agonist (GLP-1 RA)—for the treatment of type 2 diabetes in adults to improve glycemic control along with diet and exercise. Rybelsus will be available in two doses.

The same drug has been available in an injectable form (Ozempic) since December 2017.

There are some who are already calling this a game changer. And there are others who caution that the A1C-lowering and cardiovascular profiles of at least two sodium glucose co-transporter 2 (SGLT-2) drugs, Januvia (sitagliptin) and Jardiance (empagliflozin), are nearly equal to those of Rybelsus, and when considering cost, formulary benefit plans will push prescribers towards one of those two drugs.

Novo Nordisk has not yet released the price of Rybelsus but says it will this week. The Institute for Clinical and Economic Review, an independent group that analyzes drug costs, has looked at the cost-effectiveness of Rybelsus, assuming an annual price equal to Ozempic. In a draft analysis, the group estimated that Rybelsus would cost more than $6,500 a year, compared with about $1,500 for Januvia and $2,100 for Jardiance.

Because diabetes drugs—especially insulins—are under increasing pressure to be priced more affordably for lower-income Americans, it will be interesting to see how Novo Nordisk prices Rybelsus.


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