The age of the GLP-1 drug has reached yet another milestone, with the US Food and Drug Administration green-lighting Novo Nordisk’s once-daily oral semaglutide pill to treat people at high risk of cardiovascular events like heart attack and stroke.
Rybelsus (semaglutide) has now been approved it for use by adults with type 2 diabetes who have high risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack or stroke. The pill first entered the market in 2019 to improve glycemic control for diabetic adults. An oral GLP-1 receptor agonist, Rybelsus will be available in 7-mg and 14-mg doses.
“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,” said Dave Moore, Executive Vice President, US Operations of Novo Nordisk. “The semaglutide molecule has consistently demonstrated robust outcomes across multiple, large-scale trials, further reinforcing the already established cardiovascular profile it delivers for patients.”
The approval comes on the back of the SOUL Phase 3b trial, which evaluated the effects of the 14-mg dose in reducing the risk of MACE in high-risk diabetic adults. Ultimately, the 14-mg oral semaglutide showed a statistically significant 14% relative reduction in risk of MACE at four years compared with a placebo. These results built on earlier positive results that saw the drug hit its Phase 3 benchmarks, which was enough for Novo Nordisk to seek FDA approval.
“Even in the absence of a previous heart attack or stroke, adults with type 2 diabetes face an increased risk of cardiovascular events, underscoring the need for therapies that go beyond managing blood sugar,” said John B. Buse, MD, PhD, Director of the UNC Diabetes Care Center and Steering Committee Co-Chair of the SOUL trial. “Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself. This new indication, based on the SOUL data, marks even further advancement and showcases the versatility of semaglutide while expanding options for millions of people.”
There’s still no oral GLP-1 pill dedicated to treating obesity, however, Novo Nordisk has filed a separate case to the FDA seeking approval for its once-daily oral semaglutide (Wegovy). This decision from the regulatory body is expected to be handed down before the end of 2025.
People eagerly awaiting weight-loss pills should keep in mind that they’re unlikely to be much cheaper than the injectable versions of GLP-1s. While the format does away with the cost of needles, Novo Nordisk has boosted the concentration of the active drug in order for it to survive its pathway to the stomach. Competitor Eli Lilly (maker of Mounjaro), is expected to file for FDA approval of its shelf-stable oral pill Orforglipron by the end of the year.
It’s worth noting that the oral medication will come in much higher-dose formats for treating obesity – 25 mg for Novo Nordisk’s pill, which is more than double the dose of the largest Rybelsus tablet.
Source: Novo Nordisk via PR Newswire
