The drug, also known as semaglutide, is a glucagon-like peptide (GLP-1) receptor protein in pill form.
The FDA first approved the oral drug in 2019 for the purpose of managing blood sugar in type 2 diabetes patients in combination with diet and exercise. The latest move signals a label update for the drug and it can now be prescribed as initial therapy for type 2 diabetes in 7 or 14 mg.
Before the latest approval, the drug could only be prescribed after patients had tried other therapies.
“In the U.S., hundreds of thousands of people with type 2 diabetes have been prescribed this medicine as part of their type 2 diabetes treatment regimen to help lower their A1C,” Doug Langa, EVP of North America operations and president of Novo Nordisk, said in a statement.
“Rybelsus remains a pivotal part of our portfolio, making history as the first oral GLP-1 receptor agonist and helping to fuel our mission to improve the lives and health of people living with diabetes,” Langa added.
Rybelsus, the only GLP-1 treatment for the disease, works by releasing insulin from the pancreas when blood sugar is high and reduces sugar release from the liver.
The move comes as Novo Nordisk has been making a dent in the type 2 diabetes and obesity market, primarily with its drugs Rybelsus, Ozempic and Wegovy. All three are the same active drug (semaglutide), but Ozempic is an injectable version taken once a week, and Rybelsus is a daily oral tablet. Wegovy is also an injectable form of semaglutide, but is a higher-dose version than Ozempic.
Ozempic is currently only approved to treat type 2 diabetes, while Wegovy is approved for weight loss. Still, the company has commented that some providers are prescribing Ozempic for off-label use to treat obesity and help weight loss.
Due to the high demand for the drugs — exacerbated in part by that off-label use — the company has experienced shortages in the last several months. In a recent update, Novo Nordisk noted it would go slow on marketing Wegovy as it works to address supply issues.
“We will closely monitor prescribing trends and phase promotional efforts as we assess demand,” a Novo Nordisk spokesperson said. “Keeping supply stable is a priority.”