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Novo Nordisk diabetes pill wins FDA approval for first-line use

The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.

Rybelsus, which works like Novo’s Ozempic and Lilly’s Trulicity, gained FDA approval in 2019 as a daily oral alternative to those two drugs, which require weekly injections. However, that initial OK was accompanied by a recommendation doctors not prescribe Rybelsus as a first-line treatment for people with diabetes who are unable to control their blood sugar levels with diet and exercise alone. Merck’s Januvia and Lilly’s Jardiance, by comparison, already held approvals for that use.

“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,” Aaron King, a family medicine and diabetes specialist in San Antonio, Texas said in a statement from Novo Nordisk.

Rybelsus has the same active ingredient as Ozempic, but at a higher dosage and modified to aid its absorption in the stomach.

The new use for Rybelsus comes as diabetes drug competition is intensifying. In the class of drugs called GLP-1 agonists, Rybelsus is the only oral treatment, but must be taken daily, while the latest injectable drugs can be taken once a week.

Unlike Jardiance and other similar medicines, Rybelsus hasn’t been proven in a large study to significantly reduce the risk of cardiovascular death or complications, although it doesn’t appear to raise the risk of those outcomes.

Lilly, meanwhile, has launched a new type of diabetes drug called Mounjaro, which acts on GLP-1 and another hormone. Mounjaro earned $203 million in sales for Lilly between its approval in May and Sept. 30, presenting another competitive threat to Novo Nordisk.