Rybelsus can now be used as a primary or secondary prevention pill to lower the risk of major adverse cardiovascular events in at-risk patients with type 2 diabetes.
Novo Nordisk’s older-generation semaglutide pill Rybelsus can now be used to lower the risk of major heart complications in high-risk patients with type 2 diabetes.
The label expansion, granted Friday, covers the use of Rybelsus, a GLP-1 agonist, as a primary or secondary prevention option, to reduce the likelihood of major adverse cardiovascular events (MACE) such as heart attack, stroke or cardiovascular death.
Results from the Phase IIIb SOUL trial paved the way for Friday’s label expansion. With more than 9,600 patients enrolled, the study added Rybelsus to standard of care and looked at the effect of this regimen on MACE risk. Findings showed that MACE developed in 12% of patients treated with the Rybelsus combo, as compared with 13.8% of patients receiving placebo. This resulted in a treatment effect of 14%, which met statistical significance.
In March, Novo published SOUL data in the New England Journal of Medicine, prompting mixed reactions from analysts. Writing to investors at the time, BMO Capital Markets pointed to the “inconsistent benefit” of Rybelsus in the study. Despite an overall reduction in MACE risk, the analysts noted that this effect was mostly driven by the drug’s benefit on nonfatal myocardial infarctions. Other MACE components, including cardiovascular death and stroke, were not significantly reduced.
Novo is also proposing an oral formulation of its blockbuster weight-loss drug Wegovy, currently under FDA review. A decision is expected “later this year,” the pharma noted in its announcement about Rybelsus.
Rybelsus’ cardiovascular approval comes as a bright spot in what has been a difficult news flow for Novo in recent weeks. On Friday, for instance, President Donald Trump publicly promised that, through negotiations with the Center for Medicare & Medicaid Services, his government will lower the cost of Novo’s Ozempic to around $150. The pharma’s shares dipped 3% in reaction to the news.
A few days earlier, Novo announced its complete withdrawal from the cell therapy space, terminating work on many of its projects in the area, including a type 1 diabetes program. The move will leave almost all of the pharma’s 250 cell therapy employees jobless, in line with the company’s promise of laying off some 9,000 of its workers worldwide to cut costs.
Novo has also been having trouble on the manufacturing front, with one of its Indiana-based plants linked to “unacceptable” violations, according to the FDA. An inspection report made public by STAT News in August found that the plant has been fielding complaints of contamination for years, which have gone unaddressed. Novo came into possession of this particular plant when its parent company, Novo Holdings, acquired Catalent for $16.5 billion in February 2024.