FDA says Novo Nordisk’s weight problems tablet TV advert contains deceptive claims

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 concerning the drugs’s skills 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 legislation. The company requested that the drugmaker take fast motion to handle the violations, which might embody ceasing all adverts containing deceptive claims. 

In an announcement on Monday, Novo Nordisk confirmed that it obtained the letter and clarified that the advert has been working for the reason that tablet’s launch, however just isn’t the corporate’s Tremendous Bowl spot.

“We take all regulatory suggestions significantly and are within the means 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 going through 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 essential 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 gives superior advantages to different authorized GLP-1 weight reduction medication. The company stated phrases used the spot, together with “stay lighter” and “a method ahead,” indicate higher weight reduction than different therapies and added advantages past that, regardless of no proof to help these claims. 

The advert’s statements “misleadingly indicate advantages past bodily weight reduction reminiscent of emotional aid, diminished psychological burden, hope, or path for sufferers’ lives, positioning the drug as an answer to broader life challenges fairly than a remedy for a selected 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 threat 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 and marketing compounded variations of its Wegovy tablet and injections.