Still life of new Wegovy semaglutide tablets on white background. It is a prescription medication used with a low-calorie diet and physical activity.
Michael Siluk | Universal Images Group | Getty Images
The Food and Drug Administration said Novo NordiskWegovy’s television ad for its new obesity pill included “false or misleading” claims about the drug’s capabilities and benefits for patients.
In a letter to Novo on Feb. 5, the FDA said the advertising made the oral drug look bad, making its distribution a violation of federal law. The agency asked the drugmaker to take immediate action to address the violations, which could include ceasing all advertisements containing misleading claims.
In a statement Monday, Novo Nordisk confirmed receiving the letter and clarified that the ad had been running since the pill’s launch, but was not the company’s Super Bowl commercial.
“We take all regulatory comments seriously and are in the process of responding to the FDA to address their concerns regarding the presentation of the advertisement,” Liz Skrbkova, head of U.S. media and stakeholder relations at Novo, said in the release.
That adds to the growing hurdles the Danish drugmaker faces as it struggles to win back market share from its main rival. Elie Lilly and cheaper compound copiers in the booming GLP-1 market.
The company’s Wegovy pill is key to these efforts. It’s the first-ever 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 that Novo’s advertising misleadingly suggests that its pill offers greater benefits than other approved GLP-1 weight loss drugs. The agency said phrases used in the spot, including “living lighter” and “a path forward,” imply greater weight loss than other treatments and additional benefits beyond that, despite no evidence to support these claims.
The advertising’s claims “deceptively 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 disease, when this has also not been demonstrated,” the FDA said in the letter.
The FDA also reported that the ad did not adequately present risk information in both audio and text form, a requirement for television drug advertising.
Also on Monday, Novo Nordisk continued Him and herasking the court to stop the telehealth company from mass-marketing compounded versions of its Wegovy pill and injections.