Still life of the new Wegovy semaglutide tablets on a white background. It is a prescription medication used with a low-calorie diet and physical activity.
Michael Siluk | Universal Image Group | fake images
The Food and Drug Administration said NordiskThe television advertisement for its newly launched Wegovy obesity pill included “false or misleading” claims about the drug's capabilities and benefits to patients.
In a letter to Novo dated Feb. 5, the FDA said the ad mislabels 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 advertisements containing misleading claims.
In a statement on Monday, Novo Nordisk confirmed 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 ad.
“We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the filing of the announcement,” Liz Skrbkova, Novo's U.S. head of media and stakeholder relations, said in the statement.
It adds to the growing obstacles facing the Danish drugmaker as it fights to regain market share from its main rival. Eli Lilly and cheaper compound imitators in the burgeoning LPG-1 market.
The company's Wegovy pill is key to those efforts. It was the first GLP-1 obesity pill to hit the market in January, and Novo said last week that more than 170,000 U.S. patients are already taking the drug.
Bloomberg first reported on the FDA letter on Monday.
In the letter, the FDA said Novo's advertisement misleadingly suggests that its pill offers superior benefits to other approved GLP-1 weight-loss drugs. The agency said that phrases used in the ad, including “living lighter” and “a way forward,” imply greater weight loss than other treatments and additional benefits beyond that, even though there is no evidence to support those claims.
The advertisement's claims “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 adequately present risk information in both audio and text, a requirement for television drug advertising.
Also on Monday, Novo Nordisk sued him and herasking the court to stop the telehealth company from mass marketing compounded versions of its Wegovy pill and injections.
