Novo Nordisk Stock Rises. Its Diabetes Pill Cleared a Key Hurdle.

Clinical trial results showed that Rybelsus reduced cardiovascular death, heart attack and stroke in adults with Type 2 diabetes at high cardiovascular risk. (SERGEI GAPON/AFP via Getty Images)

Key Points

About This Summary

• European regulators approved Novo Nordisk’s Rybelsus to reduce cardiovascular risks in Type 2 diabetes patients.
• Rybelsus is the first oral GLP-1 drug approved in the EU with proven cardiovascular benefits, per clinical trial results.
• Novo Nordisk shares rose following the news; Rybelsus may get FDA approval later this year.

A Novo Nordisk medication for diabetes just became the first so-called GLP-1 drug taken in pill form to be approved by European regulators to reduce the risk of cardiovascular disease, sending shares of the Danish drugmaker higher early Monday.

The European Medicines Agency (EMA) has approved an update to the label of diabetes medicine Rybelsus, an oral version of semaglutide, which is also the active ingredient in its blockbuster diabetes and weight-loss drugs Ozempic and Wegovy, Novo said in a statement.

The decision was based on clinical trial results that showed the treatment reduced cardiovascular death, heart attack and stroke by 14% compared with patients who received a placebo in adults with Type 2 diabetes at high cardiovascular risk, Novo said.

It makes Rybelsus the first drug in the class of GLP-1s—a gut hormone that naturally occurs in the body and helps to control blood sugar levels and suppress appetite—to become available in the EU for Type 2 diabetes with a proven cardiovascular benefit, possibly clearing the way for approval by the U.S. Food and Drug Administration later this year.

“Heart problems are the leading cause of disability and death for people living with Type 2 diabetes,” said Novo’s head of international operations Emil Kongshøj Larsen. “Treatments that also address heart problems are key to improving not only health outcomes, but also quality of life.”

Novo Nordisk shares rose 3.2% in Denmark, while its American depositary receipts gained 2.3% to $56.12 in early trading. Shares of rival Eli Lilly were down 0.5%.

Shares of Novo have suffered in the past year, amid concerns it is losing market share to Lilly as well as to compounding pharmacies selling cheaper copycat versions of semaglutide.

Write to Elsa Ohlen at elsa.ohlen@barrons.com