Dive Brief:

• Novo Nordisk’s diabetes pill Rybelsus cut the risk of heart attacks, strokes and cardiovascular death by 14% in a Phase 3 trial of people with diabetes and established heart or kidney disease, the company said Monday. The study, called SOUL, tested Rybelsus against a placebo in trial participants already receiving standard medications.
• Novo intends to ask the Food and Drug Administration around the end of 2024 to approve the medication to protect the heart health of people with diabetes. Should the FDA agree, Novo’s pill would join diabetes medicines like Boehringer Ingelheim and Eli Lilly’s Jardiance and AstraZeneca’s Farxiga, which are proven to have similar benefits.
• The data comes as Novo and Lilly are racing to broaden the reach of their fast-selling GLP-1 drugs and stay ahead of competitors. Like the injectable form of Rybelsus, the oral version has been able to show that it can help people with obesity lose weight. Novo hasn’t yet filed for approval in obesity, however.

Dive Insight:

Heart disease is a common complication of diabetes, and one that can lead to premature death. Regulators, then, want to make sure that drugs that lower blood sugar don’t increase the risk of cardiovascular problems. So do doctors and insurers. 

Rybelsus is an oral form of semaglutide, the active ingredient in the widely used drug Novo sells as Ozempic for diabetes and Wegovy for obesity. The FDA has already cleared use for both of those drugs in preventing heart problems, so it isn’t necessarily surprising to see Rybelsus achieve the same type of benefit in a clinical trial. 

In the SOUL study, Novo enrolled more than 9,600 people with diabetes and established heart or kidney disease. Trial participants were randomized to receive Rybelsus or a placebo on top of their standard medication. They were followed for up to five years to measure the difference in rates of myocardial infarction, stroke or cardiovascular death.

Novo said that roughly half of study volunteers got a so-called SGLT2 inhibitor like Jardiance or Farxiga during the trial and likely benefited from taking them. Nonetheless, Rybelsus was associated with a reduction in the risk of infarctions, strokes and death, though Novo didn’t disclose more specifics beyond the 14% figure in Monday’s announcement.

Should Novo submit the data to regulators as planned — around the end of 2024 or in early 2025 — the FDA could broaden use of Rybelsus about a year from now.

Less clear, though, is whether Novo will ultimately seek clearance of Rybelsus as an obesity treatment. The Denmark-based company announced positive data in May 2023 and outlined plans to seek FDA approval sometime last year. However, an investor presentation in March, as well as the company’s website, describes the drug as in Phase 3 development.

A Novo spokesperson hasn’t yet responded to a request for comment from BioPharma Dive.

Novo has struggled to manufacture enough semaglutide to meet demand for Wegovy, which is sold at higher dosage strengths than Ozempic. Rybelsus has an even larger amount of semaglutide than both of the injectable drugs, and even higher doses were evaluated when the drug was tested as an obesity medicine.