The Meals and Drug Administration stated Novo Nordisk‘s TV commercial for its newly launched Wegovy tablet for weight problems included “false or deceptive” claims in regards to the drugs’s talents and advantages to sufferers.
In a letter to Novo dated Feb. 5, the FDA stated the advert misbrands the oral drug, making its distribution a violation of federal regulation. The company requested that the drugmaker take quick motion to handle the violations, which might embody ceasing all advertisements containing deceptive claims.
In an announcement Monday, Novo Nordisk confirmed that it obtained the letter and clarified that the advert has been operating because the tablet’s launch, however just isn’t the corporate’s Tremendous Bowl spot.
“We take all regulatory suggestions significantly and are within the technique of responding to the FDA to handle their issues relating to the commercial’s presentation,” Liz Skrbkova, Novo’s head of U.S. media and stakeholder relations, stated within the assertion.
It provides to the mounting hurdles the Danish drugmaker is dealing with because it scrambles to win again market share from chief rival Eli Lilly and cheaper compounded copycats within the booming GLP-1 market.
The corporate’s Wegovy tablet is vital to these efforts. It was the first-ever GLP-1 tablet for weight problems to enter the market in January, and Novo final week stated greater than 170,000 American sufferers are already taking the drug.
Bloomberg first reported on the FDA letter on Monday.
Within the letter, the FDA stated Novo’s advert misleadingly suggests its tablet affords superior advantages to different permitted GLP-1 weight reduction medicine. The company stated phrases used within the spot, together with “stay lighter” and “a method ahead,” indicate better weight reduction than different remedies and added advantages past that, regardless of no proof to help these claims.
The advert’s statements “misleadingly indicate advantages past bodily weight reduction equivalent to emotional reduction, decreased psychological burden, hope, or course for sufferers’ lives, positioning the drug as an answer to broader life challenges reasonably than a remedy for a particular situation, when this has additionally not been demonstrated,” the FDA stated within the letter.
The FDA additionally flagged the advert for failing to correctly current danger data in each audio and textual content, a requirement for tv drug promoting.
Additionally on Monday, Novo Nordisk sued Hims & Hers, asking the courtroom to cease the telehealth firm from mass advertising compounded variations of its Wegovy tablet and injections.
