Novo Nordisk’s oral semaglutide lowered the risk of certain heart events in a late-phase study in people with type 2 diabetes and related metabolic conditions, sparking plans to file for a label expansion for the non-injectable form of its GLP-1 drug.
The Danish company’s oral semaglutide Rybelsus hit the primary endpoint in the 9,650-participant Phase 3 SOUL trial, reducing major adverse cardiovascular events (MACE) by around 14% compared with placebo. MACE was defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
But detailed data from the trial will have to wait until next year when Novo plans to reveal full results at a medical conference. Nonetheless, the company plans to file the data with US and EU regulators around the end of the year.
SOUL enrolled people with type 2 diabetes and cardiovascular disease or chronic kidney disease, almost half of whom were taking standard-of-care SGLT2 inhibitors at some point in the study, according to a Monday release.
Rybelsus secured an FDA approval back in 2019 for type 2 diabetes. It is “crucial” to have treatment options that address both diabetes and cardiovascular disease because one in three adults have both conditions, Novo’s head of development Martin Holst Lange said in the release.
In the second quarter, Rybelsus sales were up almost 50% from the same time period last year to DKK 5.9 billion ($858 million). Meanwhile, Novo’s injectable form of semaglutide for weight loss, Wegovy, made DKK 11.7 billion ($1.7 billion) in the second quarter.
In March, the FDA cleared Wegovy to reduce the risk of cardiovascular death, heart attack and stroke in adults with heart disease who are either obese or overweight. The approval meant Medicare Part D had to start covering Wegovy for certain patients, marking a major shift for public payers that had previously not covered weight loss drugs.