The U.S. Food and Drug Administration (FDA) has accused Novo Nordisk (NVO) (NONOF) of violating federal law by including “misleading” claims in a TV commercial for its recently launched oral weight loss therapy, the Wegovy pill.
The regulator sent a letter to the Danish drugmaker on Thursday notifying the company to take immediate corrective action, including a potential discontinuation of all promotional campaigns containing the alleged misleading claims.
The FDA noted that “live lighter,” “a way forward,” and several other phrases used in the advertisement imply that the Wegovy pill offers superior efficacy and safety over other GLP-1 treatments approved for weight loss.
“Specifically, these claims and presentations misleadingly imply that Wegovy in pill form uniquely enables patients to achieve outcomes that were not previously possible with other GLP-1 treatments for weight loss,” the agency said in the letter dated Feb. 5.
Novo (NVO) has 15 days to submit a written response detailing any plans to cease all communications that are allegedly in violation of the law and, if it believes that its promotional activities comply with the law, to provide reasoning to back up those claims.
The company confirmed it received the letter and stated that it has been running the advert since the launch of the Wegovy pill in January. “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,” added Liz Skrbkova, head of U.S. media and stakeholder relations for NVO.
Novo (NVO) aired a star-studded Super Bowl ad on Sunday, its first-ever commercial for football’s biggest event, as the company tries to regain market share lost to weight loss rival Eli Lilly (LLY) and companies such as Hims & Hers (HIMS), which market compounded GLP-1s.
After regulatory pushback, HIMS abandoned its plans to offer cheaper compounded versions of the Wegovy pill on Saturday. However, Novo (NVO) filed a lawsuit against the company alleging that the telehealth platform infringed on a key patent related to semaglutide, the active ingredient of Wegovy.