Novo Nordisk secures EU Label update for Rybelsus to include cardiovascular protection

DENMARK—Novo Nordisk has gained approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to update the label for its oral diabetes medication, Rybelsus (oral semaglutide).

This approval highlights the drug’s newly recognized cardiovascular benefits, further strengthening its position in diabetes management.

This development closely follows Teva Pharmaceutical’s recent approval by the U.S. Food and Drug Administration (FDA) for its generic version of Saxenda (liraglutide), an injectable weight-loss drug originally developed by Novo Nordisk.

 While Teva’s approval focuses on a different medication, the timing underscores the growing attention on treatments addressing both diabetes and related health concerns, such as obesity and cardiovascular risks.

The updated label for Rybelsus will now officially include evidence from the SOUL clinical trial, which demonstrated significant cardiovascular protection.

This makes Rybelsus the first oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the European Union to show proven benefits in reducing severe cardiovascular events.

These events include cardiovascular death, heart attacks, and strokes, which are common complications for people living with type 2 diabetes (T2D).

The SOUL study was a large-scale Phase IIIb clinical trial that enrolled 9,650 adults with T2D who either had established atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease (CKD), conditions that increase the risk of heart problems.

Results showed that patients treated with Rybelsus experienced a 14% reduction in major adverse cardiovascular events compared to those who did not receive the drug.

Emil Kongshøj Larsen, Novo Nordisk’s Executive Vice President of International Operations, emphasized the importance of this milestone.

He explained that heart disease is the leading cause of death and disability among people with type 2 diabetes.

Therefore, treatments that effectively address both blood sugar control and heart health are crucial for improving patients’ overall well-being and quality of life.

Larsen pointed out that this approval makes semaglutide the only oral GLP-1 RA that not only lowers blood sugar and body weight but also reduces cardiovascular risks.

Rybelsus was launched in 2019 and is currently available in 48 countries, with over 2.4 million patients using it for managing T2D.

The medication has a strong track record in helping patients control blood glucose levels and lose weight compared to other diabetes treatments.

Novo Nordisk is also awaiting a decision from U.S. regulators on a similar label update for Rybelsus, which includes cardiovascular benefits and is expected later this year.

Additionally, the company has applied for approval of a 25 mg oral semaglutide dose to treat adults with obesity or overweight who also have cardiovascular disease, with a verdict anticipated before year-end.

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