Novo Nordisk’s Rybelsus has become the first oral GLP-1 agonist to pick up a regulatory approval for cardiovascular risk reduction, after getting a green light from the EMA’s human medicine committee.
The CHMP has approved an update to the Rybelsus (semaglutide) label in the EU to include data from the SOUL trial, which showed that the drug achieved a 14% reduction in cardiovascular death, heart attack and stroke compared to placebo in patients with type 2 diabetes who were at high cardiovascular risk.
Updated results from SOUL are due to be presented later this week at the European Association for the Study of Diabetes (EASD) congress, which started today in Vienna, Austria.
Rybelsus has been approved in the EU since 2020 as a daily, oral treatment for type 2 diabetes, and has become a blockbuster for Novo Nordisk, albeit a relatively minor one in comparison to the Danish group’s big-selling injectable semaglutide products, Ozempic for diabetes and obesity shot Wegovy.
Sales were DKK 11.3 billion ($1.78 billion) in the first six months of the year, while Ozempic brought in DKK 64.5 billion and Wegovy added DKK 36.9 billion.
It’s worth noting that growth for the injectables has slowed due to an increasingly competitive market, forcing Novo Nordisk to slash its sales forecasts for the year, replace its chief executive, and start a major cost-reduction drive that will see approximately 11% of its workforce – some 9,000 staffers – lose their jobs.
With that in mind, the Rybelsus approval is viewed as a modest commercial lift to Novo Nordisk, given that the company has already indicated it will de-prioritise the drug slightly as it focuses on Ozempic and Wegovy, but a milestone for the GLP-1 category overall.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes,” said Emil Kongshøj Larsen, head of international operations at Novo Nordisk.
“Treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” he added. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
The FDA in the US is also reviewing an application to extend Rybelsus’ label based on the SOUL data, but there is no question that the bigger prize for Novo Nordisk is an ongoing review of a higher-dose formulation of oral semaglutide for adults living with obesity or overweight and cardiovascular disease, due around the turn of the year.
If approved, that 25mg formulation could become the first oral GLP-1 agonist indicated for chronic weight management, ahead of rivals like Eli Lilly’s orforglipron.
