Novo Nordisk wins U.S. approval for first-of-its-kind oral diabetes drug
The U.S. Food and Drug Administration on Friday approved an oral version of Novo Nordisk's diabetes drug semaglutide, a boost for the Danish drugmaker which hopes to transform the market by offering patients a non-injectable treatment. Copenhagen-listed shares of the company rose 2.6% in late European trading.
The world's biggest producer of diabetes drugs already sells an injectable once-weekly version of semaglutide under the brand name Ozempic at nearly $800 per month.
Novo did not disclose what it plans to charge for the new oral treatment, called Rybelsus, but said it would be "competitively priced" with other drugs in the same "GLP-1" class of medicines.
Eli Lilly and Co's Trulicity, an injectable rival, has a list price of $759.40 per month, according to Lilly's website.
Rybelsus, which will be available in the United States in the fourth quarter, stimulates insulin production in patients with type 2 diabetes, the most common form of the disease, and is meant to be taken once a day.
Novo is betting on the success of its launch as the company faces pricing pressures from competitors and U.S. lawmakers, who have been critical of rising drug costs.
The approval makes Rybelsus the first drug of its class on the market that does not have to be injected, an advantage Novo hopes to capitalize on, as it sells to diabetics with an aversion to shots.
"The oral administration is likely to make oral semaglutide competitive for quite some time," Pareto Securities analyst Johan Unnerus said.
The closest competition is probably Novo's Ozempic, Lilly's Trulicity and, in some way, Merck & Co Inc's Januvia, he added.
The brokerage expects Rybelsus sales of at least DKK 36.6 billion ($5.40 billion) in 2026.
The drug's label comes with a boxed warning, the FDA's harshest, flagging a potential increased risk of thyroid c-cell tumors. It also states that Rybelsus is not recommended as the first choice of medicine for treating diabetes.
Novo has invested in manufacturing facilities in North Carolina to supply the U.S. market with the oral pill.
The company said it plans to source initial supply from Denmark, but would manufacture Rybelsus in the United States in future. Novo is also testing semaglutide as a treatment for obesity and non-alcoholic steatohepatitis, a fatty liver disease.