FDA Expands Approval for Novo Nordisk's Rybelsus, Setting New Benchmark for Oral Diabetes Medications

The U.S. Food and Drug Administration (FDA) has granted an expanded approval for Novo Nordisk's oral semaglutide treatment, Rybelsus, marking a significant advancement in the management of Type 2 diabetes and associated cardiovascular risks. This latest development positions Rybelsus as a pioneering oral medication in the GLP-1 therapy class, now recognized for its cardiovascular benefits.

Expanded Indication for Cardiovascular Risk Reduction

The FDA has approved Rybelsus tablets at doses of 7 mg and 14 mg to reduce the risk of major adverse cardiovascular events (MACE) in adults with Type 2 diabetes who are at elevated risk. This expansion follows similar approvals for Novo Nordisk's injectable semaglutide treatments, Ozempic and Wegovy.

Dave Moore, chief of Novo Nordisk's U.S. operations, emphasized the significance of this approval, stating, "As the only FDA-approved GLP-1 therapy in a pill, now recognized for its proven cardiovascular benefits, a new benchmark has been set for future oral innovations."

Clinical Trial Results Support Approval

The expanded indication is based on a comprehensive phase 3 trial involving 9,650 adults with Type 2 diabetes and established cardiovascular disease or chronic kidney disease. Key findings from the study include:

• A 14% reduction in the risk of MACE with the 14 mg dose of Rybelsus compared to placebo
• MACE occurrence in 12% of patients on Rybelsus versus 13.8% on placebo over a four-year follow-up period
• Adverse events leading to discontinuation in 15.5% of Rybelsus participants, primarily due to gastrointestinal disorders, compared to 11.6% in the placebo group

Market Position and Future Prospects

While Rybelsus may be overshadowed by Novo Nordisk's blockbuster injections Ozempic and Wegovy, it has demonstrated significant market presence, generating 11.3 billion Danish kroner ($1.7 billion) in the first half of this year. The treatment's journey began with its original approval in 2019 for Type 2 diabetes patients not achieving their A1C goals with other antidiabetic treatments. In 2023, it gained approval as a first-line treatment for Type 2 diabetes.

Novo Nordisk continues to explore Rybelsus's potential, with ongoing tests for its efficacy in reducing the risk of heart failure. This latest cardiovascular risk reduction approval not only strengthens Rybelsus's position in the market but also sets a new standard for oral diabetes medications, potentially influencing future drug development in the field.