Still life of the new Wegovy semaglutide tablets on a white background. Its a prescription medicine used with a reduced calorie diet and .and physical activity.
Michael Siluk | Universal Images Group | Getty Images
The Food and Drug Administration said Novo Nordisk‘s TV advertisement for its newly launched Wegovy pill for obesity included “false or misleading” claims about the medicine’s abilities and benefits to patients.
In a letter to Novo dated Feb. 5, the FDA said the ad misbrands the oral drug, making its distribution a violation of federal law. The agency requested that the drugmaker take immediate action to address the violations, which could include ceasing all ads containing misleading claims.
In a statement Monday, Novo Nordisk confirmed that it received the letter and clarified that the ad has been running since the pill’s launch, but is not the company’s Super Bowl spot.
“We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation,” Liz Skrbkova, Novo’s head of U.S. media and stakeholder relations, said in the statement.
It adds to the mounting hurdles the Danish drugmaker is facing as it scrambles to win back market share from chief rival Eli Lilly and cheaper compounded copycats in the booming GLP-1 market.
The company’s Wegovy pill is key to those efforts. It was the first-ever GLP-1 pill for obesity to enter the market in January, and Novo last week said more than 170,000 American patients are already taking the drug.
Bloomberg first reported on the FDA letter on Monday.
In the letter, the FDA said Novo’s ad misleadingly suggests its pill offers superior benefits to other approved GLP-1 weight loss drugs. The agency said phrases used in the spot, including “live lighter” and “a way forward,” imply greater weight loss than other treatments and added benefits beyond that, despite no evidence to support those claims.
The ad’s statements “misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition, when this has also not been demonstrated,” the FDA said in the letter.
The FDA also flagged the ad for failing to properly present risk information in both audio and text, a requirement for television drug advertising.
Also on Monday, Novo Nordisk sued Hims & Hers, asking the court to stop the telehealth company from mass marketing compounded versions of its Wegovy pill and injections.