Novo Nordisk type 2 diabetes pill Rybelsus now has FDA approval for use as a first-line therapy, a change that enables the fast-growing product to reach an even larger group of patients in the competitive market of diabetes medicines.
Once-daily Rybelsus is indicated for use alongside diet and exercise as a way to help control levels of glucose in the blood. But when the pill was initially approved four years ago, the drug label stated it should not be used as an initial treatment for type 2 diabetes. That limitation has been removed, Novo Nordisk announced late Thursday.
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The main component of Rybelsus is semaglutide, a peptide that activates the glucagon-like peptide (GLP-1) receptor. Doing so increases the release of insulin from the pancreas when blood sugar is high. The drug also decreases the release of sugar from the liver and slows the process of food leaving the stomach after a meal.
Semaglutide is commercially available in different forms. Once-weekly injectable semaglutide was first, winning FDA approval in 2017 in type 2 diabetes. Novo Nordisk markets that product as Ozempic. The 2019 FDA nod for Rybelsus made the drug the first oral GLP-1 agonist authorized for the market. Novo Nordisk developed this version of semaglutide with an ingredient that facilitates stomach absorption, enabling the drug to be formulated as a pill.
Other pills approved as first-line type 2 diabetes therapies include Januvia from Merck and Jardiance from Eli Lilly. Januvia blocks an enzyme called DPPP-4, an approach intended to slow the inactivation of hormones important to maintaining stable blood glucose levels. Jardiance blocks a target called SGLT2, which has the effect of reducing reabsorption of glucose in the kidneys so it can be excreted in urine.
Lilly does have a GLP-1 targeting drug, Trulicity. But that blockbuster drug is administered as a once-weekly injection. When it was first approved in 2014, Trulicity’s label stated it was not recommended as a first-line diabetes treatment. That limitation is no longer on the current Trulicity label. Lilly’s newest diabetes product, Mounjaro, brings a dual approach to diabetes by activating GLP-1 as well as another target called GIP. This once-weekly injection also does not have a limitation recommending against first-line use. Novo Nordisk sought labeling parity with its competition.
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“Knowing that other GLP-1s with a similar safety profile have received FDA approval without this limitation of use, Novo Nordisk went back to the FDA to request that the limitation of use be removed,” a company spokesperson said via email.
Rybelsus is following in Ozempic’s footsteps as a blockbuster seller. Novo Nordisk reported more than 7.2 billion Danish krone (more than $1 billion) in sales for the pill through the first nine months of 2022, a 140% increase compared to the same period in the prior year. In diabetes, Ozempic and Rybelsus together account for more than half of the global GLP-1 market, the company said in its presentation of third quarter 2022 financial results. Rybelsus’s move into first-line treatment will make more type 2 diabetes patients eligible for the therapy.
“The removal of the limitation of use is an important step forward for people living with type 2 diabetes and provides the option for Rybelsus to be taken earlier,” Aaron King, a family medicine and diabetes specialist in San Antonio, said in Novo Nordisk’s announcement. “By taking Rybelsus first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilize this medicine early in their diabetes treatment journeys.”
Photo: Jean-Francois Monier/AFP, via Getty Images
