UPDATE 1-U.S. FDA approves oral diabetes drug from Novo Nordisk

Tamara Mathias

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Sept 20 (Reuters) - 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 2.4% 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.

The new oral treatment, called Rybelsus, 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. (http://bit.ly/2kWSKJH)

Novo is betting on the success of the launch of the oral drug, which belongs to a class of medicines called GLP-1s, as it 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 the company 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, Eli Lilly's Trulicity and, in some way, Merck & Co Inc's Januvia, he added.

The brokerage expects oral semaglutide sales of at least DKK 36.6 billion ($5.40 billion) in 2026.

Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed.

The drug's label comes with a boxed warning, the FDA's harshest, advising users of an increased risk thyroid c-cell tumors. It also states that Rybelsus is not recommended as the first choice of medicine for treating diabetes.

Novo is building manufacturing capacity in the United States to support supply of oral semaglutide, as well as future oral products.

Last month, the company said it had bought a factory in North Carolina to assist in manufacturing and packaging the oral pill for patients with type 2 diabetes.

The company is also testing semaglutide as a treatment for obesity and non-alcoholic steatohepatitis, a fatty liver disease. ($1 = 6.7824 Danish crowns) (Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh Kuber)