Healthcare & Pharmaceuticals

U.S. FDA approves Novo Nordisk's semaglutide as obesity treatment

3 minute read

Flags are seen outside Novo Nordisk headquarters in Copenhagen, Denmark, February 5, 2020. REUTERS/Jacob Gronholt-Pedersen/Files

June 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Danish drugmaker Novo Nordisk's (NOVOb.CO) once-weekly semaglutide drug as a treatment for obesity, a condition that affects nearly 70% of American adults.

The drugmaker said it was expecting to launch the drug, which would be sold under the brand name Wegovy, in the United States later in June 2021.

The regulatory nod is a big win for Novo, which has seen its core insulin business suffer from tough competition, prompting it to turn toward newer diabetes and obesity drugs to revive growth.

Novo's revenue growth has been driven by sales of its newer GLP-1 products, which imitate an intestinal hormone that stimulates insulin production, lowers appetite and increases feelings of fullness in patients.

"There is a huge, huge unmet need here," Doug Langa, Novo's executive vice president for North America operations, told Reuters on Thursday, ahead of the FDA's decision.

Langa hopes the improved efficacy of semaglutide will help Novo grow the market further, particularly by convincing more doctors to prescribe the drug while also getting more insurers to include it in their coverage.

Novo, the first to introduce GLP-1 drugs on the obesity market, could benefit from more rivals entering the field to help brand obesity drug treatment among general practitioners.

The FDA approved a dosage of 2.4 milligram semaglutide as a treatment for adults with obesity as an adjunct to physical exercise and reduced-calorie diet, Novo said.

The under-the-skin injection is the first drug to be approved for chronic weight management in adults with general obesity or who are overweight since 2014, the FDA said. (https://bit.ly/34OdzdH)

Novo is gearing up for the launch of semaglutide with around 350 to 400 sales representatives ready to sell the product, Langa said, but he declined to disclose how much Novo expected to spend on marketing.

Reporting by Nikolaj Skydsgaard in Copenhagen; Editing by Anil D'Silva

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