On Friday, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Novo Nordisk's Rybelsus, the only oral GLP-1 drug. Based on the results of the SOUL cardiovascular outcomes study, the drug is now officially approved to reduce the risk of major adverse cardiovascular events (MACE) (such as heart attack, stroke or cardiovascular death) in adults at high risk for type 2 diabetes.
This makes Rybelsus the only GLP-1 pill approved for both primary and secondary cardiovascular prevention in this patient group.
This is a tremendous strategic success that adds a new, defensible level to the moat of Rybelsus. From a practical perspective, the barrier to starting injectable therapy for many patients with type 2 diabetes is enormous. This approval overcomes that hurdle and transforms Rybelsus from a simple diabetes pill into an essential, dual-action therapy that also protects the heart.
It provides Novo's sales team with an incredibly compelling, evidence-based reason to position Rybelsus not just as an alternative to their own injectables, but as a superior choice over an entire class of competing oral drugs that lack this cardiovascular data. This increases the overall value of the drug and should significantly accelerate its acceptance and market share gains.
This approval brings proven cardiovascular protection into a simple pill. This is a turning point for early and widespread use. The relative risk reduction of 14% in the SOUL study is both statistically significant and clinically meaningful. It allows doctors to tell high-risk patients that this pill not only helps with diabetes, but also actively protects them against heart attack or stroke.
For these reasons, the drug goes from being merely a "diabetes drug" to an essential, life-sustaining therapy, dramatically improving the likelihood that a patient will start and stay on treatment.
In my opinion, this is an important strategic success for $NOVO B (+2.55%) which significantly extends Rybelsus' competitive advantage. The drug now has a strong, evidence-based marketing promise that no other oral GLP-1 can match. This approval transforms Rybelsus from a convenient alternative to injections to a stand-alone, best-in-class cardiometabolic therapy and gives physicians a compelling reason to prescribe it over other oral preparations without this cardiovascular benefit. This solidifies Novo's leading position in the overall cardiometabolic space.
PS: This is not the oral GLP1 variant which will be launched in 2026 before $LLY (+0.29%) comes onto the market ✌️
