The Food and Drug Administration stated: novo nordiskA television advertisement for the newly launched obesity drug Wegovy contained “false or misleading” claims about the drug’s capabilities and benefits to patients.
In a Feb. 5 letter to Novo, the FDA said the advertisement misbranded the oral drug and its distribution was a violation of federal law. The agency urged pharmaceutical companies to take immediate steps to address violations, including suspending all advertising containing misleading statements.
Novo Nordisk acknowledged in a statement Monday that it had received the letter and clarified that the ad, which has been running since the pill’s launch, is not the company’s Super Bowl spot.
“We take feedback from all regulators seriously and are working with the FDA to address concerns about the display of our ads,” Liz Skrivkova, Novo’s head of U.S. media and relations, said in a statement.
The hurdles facing Danish drugmakers as they struggle to regain market share from their biggest rivals get even higher. Eli Lilly and cheap compounded counterfeits in the rapidly growing GLP-1 market.
The company’s Wegovy pill is key to these efforts. It is the first GLP-1 pill to treat obesity, which hit the market in January, and Novo announced last week that more than 170,000 patients in the United States are already taking the drug.
Bloomberg first reported the FDA’s letter on Monday.
The FDA said in the letter that Novo’s advertising misleadingly suggests that the company’s pills are more effective than other approved GLP-1 weight loss drugs. The agency said phrases used there, such as “living lightly” and “moving forward,” suggested greater weight loss and greater benefits than other treatments, despite no evidence to support those claims.
In its letter, the FDA said the ad’s language “misleads about benefits beyond physical weight loss, such as psychological relief, reduced psychological burden, hope, and direction in a patient’s life, and positions the drug as a solution to a broader range of life challenges rather than a treatment of specific symptoms, which is also unsubstantiated.”
The FDA also issued a warning to the ad for not adequately presenting risk information in both audio and text, a requirement for television drug ads.
Also on Monday, Novo Nordisk filed a lawsuit. him and herasked a court to stop the telemedicine company from selling large quantities of a combination pill and injectable version of Wegobee.
