The Food and Drug Administration has warned Novo Nordisk that a television advertisement promoting its newly launched Wegovy pill for obesity contains "false or misleading" claims.
The agency said that the spot misbrands the drug and violates federal law, CNBC reported Monday.
In a letter dated Feb. 5, the FDA said the ad overstates the oral drug's abilities and benefits, and requested that Novo take immediate corrective action, which could include pulling all advertisements that contain the disputed claims.
Novo Nordisk confirmed Monday that it received the FDA letter and said it is responding to the agency's concerns. The company said the ad has been running since the pill was launched 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," said Liz Skrbkova, Novo's head of U.S. media and stakeholder relations.
The warning added to growing challenges for the Danish drugmaker as it tries to defend its position in the rapidly expanding market for GLP-1 weight-loss drugs, CNBC reported.
Novo is facing stiff competition from chief rival Eli Lilly, as well as pressure from lower-cost compounded versions of its medications.
The Wegovy pill is central to Novo's strategy. It became the first GLP-1 pill approved for obesity when it entered the U.S. market in January, and the company said last week that more than 170,000 Americans are already taking it.
According to the agency, Novo's advertisement misleadingly suggests that the Wegovy pill offers superior benefits compared with those of other approved GLP-1 weight loss treatments.
The FDA said phrases used in the commercial, including "live lighter" and "a way forward," imply greater weight loss and added benefits beyond what has been demonstrated in clinical evidence.
The agency also said the ad improperly suggests emotional and psychological benefits, such as reduced mental burden or broader life improvement, positioning the drug as a solution to life challenges rather than a treatment for obesity.
"These statements misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients' lives," the FDA wrote, adding that such claims have not been supported by evidence.
The FDA further faulted the advertisement for failing to adequately present risk information in both audio and text, a requirement for televised prescription drug ads.
Separately on Monday, Novo Nordisk filed a lawsuit against Hims & Hers, seeking to block the telehealth company from mass marketing compounded versions of Wegovy pills and injections, as the drugmaker moves to protect its products amid intensifying competition in the GLP-1 market.
Brian Freeman ✉
Brian Freeman, a Newsmax writer based in Israel, has more than three decades writing and editing about culture and politics for newspapers, online and television.
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