A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi.
Among the four new letters is one regarding the first TV ad for Novo’s recently launched Wegovy pill. The commercial debuted during the 2026 Golden Globe Awards in January, as Ed Cinca, Novo’s senior VP of marketing and patient solutions, told Fierce Pharma Marketing in a recent interview discussing a subsequent ad for the oral med that aired during this week’s Super Bowl LX.
The initial “Live Lighter” spot touts the Wegovy pill’s weight-loss bona fides and greater convenience, over a montage of happy-looking people spending time with loved ones at a roller rink, a carnival and a food truck.
In its Feb. 5 letter (PDF), the FDA primarily took issue with what it perceived as the ad’s implication that the Wegovy pill offers improvements in efficacy, safety and even emotional relief over other GLP-1s thanks to its use of phrases like “live lighter” and “a way forward.”
“FDA is not aware of data to support the implication that Wegovy, in pill form, is superior to other currently approved GLP-1 treatments for weight loss in terms of efficacy and/or safety. Therefore, claims and presentations suggesting such are misleading,” the agency wrote, giving Novo 15 working days to respond to its concerns.
In a statement sent to Fierce, a Novo spokesperson said the company is “in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation,” emphasizing that it takes regulatory feedback seriously.
“Novo Nordisk is committed to responsible advertising that is accurate, balanced and meets all FDA regulatory and compliance standards,” the statement continued. “We believe in Wegovy and it is our hope that patients who can benefit from it are aware of it and encouraged to have an informed discussion with their healthcare professional.”
Also in the FDA’s crosshairs are a pair of ads for argenx’s Vyvgart Hytrulo, each of which earned a Jan. 30 untitled letter from the regulator.
One missive (PDF) focused on a commercial touting the prefilled syringe version of the med for generalized myasthenia gravis (gMG). The ad launched last year and follows a trio of people at work, on vacation and at a football game, each celebrating how the self-administered syringes allow for treatment “my way” and that fits “my plans.”
According to the FDA, that imagery could suggest to viewers that “the administration of Vyvgart Hytrulo can be easily completed while traveling or attending an outdoor sporting event, thereby oversimplifying the administration process.”
The agency also noted that certain risk information related to hypersensitivity reactions and infusion/injection-related reactions was absent from the ad’s major statement.
Finally, in what has become a common refrain in months-long crackdown on direct-to-consumer drug advertisements, the FDA took issue with the commercial’s “attention-grabbing visuals,” which it said may “interfere with comprehension of the major statement.”
The other letter (PDF) comprised similar complaints, this time focusing on an ad that also rolled out last year and depicts how Vyvgart Hytrulo can help those with chronic inflammatory demyelinating polyneuropathy (CIDP) “Live Vyvidly.”
For one thing, per the FDA, the ad’s scenes “create a misleading impression that all patients with CIDP, while on treatment with Vyvgart Hytrulo, can expect to engage in these activities (e.g., playing golf, driving a car) and remain functional with little to no diminishment of or restrictions to daily activities, when this has not been demonstrated.”
On a similar note, the FDA highlighted the commercial’s claim that Vyvgart Hytrulo had been demonstrated in studies to reduce “the risk of arm and leg symptoms getting worse.” The agency called that wording “misleading,” since the referenced trial measured the time to clinical deterioration, which “is not the same as the risk of worsening,” it wrote.
Elsewhere, the letter accused the ad of “oversimplifying” the injection process and, in a repeat of the other note, railed against missing risk information about hypersensitivity reactions and infusion/injection-related reactions, and against the “attention-grabbing visuals.”
An argenx spokesperson confirmed receipt of the two letters in a statement to Fierce and added, “We are reviewing the letters and look forward to working with [the] FDA to resolve their concerns as quickly as possible. argenx remains committed to ensuring that patients receive accurate information about VYVGART Hytrulo in a clear, appropriate, and compliant manner.”
Finally, the FDA also uploaded this week an untitled letter (PDF) sent Feb. 6 to Swedish drugmaker Sobi about a DTC ad for its myelofibrosis treatment Vonjo.
In addition to the requisite criticism of the “attention-grabbing visuals, frequent scene changes, and background music” amid the ad’s major statement of risk and side effects, the agency listed out three other ways in which it found the commercial “misleading.”
For one, it wrote, the ad’s scenes of an elderly man having a lively day out with his dog and its tagline of “Turn the page with Vonjo” could suggest that the medication can improve social and emotional functioning, though that wasn’t demonstrated in clinical trials.
Elsewhere, the ad notes that Vonjo can be used by adults with low platelet counts but doesn’t specify what “low” entails, constituting a failure to “adequately communicate the indication for Vonjo,” per the FDA. And, finally, the agency wrote that the ad “omits important risk information associated with the drug,” namely, certain potential side effects.
As with the other letters, the FDA gave Sobi 15 days to address its complaints. Sobi did not immediately respond to Fierce’s request for comment.