Novo Nordisk's Wegovy pill ad 'misleading', says FDA

Novo Nordisk has been criticised by the FDA for a TV advertisement for its recently launched Wegovy pill, which the agency claims makes "false and misleading" claims.

The US regulator has made its displeasure known in a letter (PDF) which says the ad erroneously claims that the oral formulation of GLP-1 agonist Wegovy (semaglutide) – due to its route of administration – "offers an advancement or improvement" over injectable GLP-1-targeting drugs.

The ad aired on US TV in January, according to the letter, which maintains that the totality of claims made within it – including that "weight loss has never looked like this" and "weight loss with Wegovy isn't a shortcut, it's a way forward" – imply that oral Wegovy allows patients achieve outcomes that were not previously possible with other GLP-1 drugs.

"For example, the claims 'live lighter' and 'a way forward' misleadingly imply additional weight loss compared to other currently approved GLP-1 treatments, when this has not been demonstrated," according to the letter.

"Additionally, they misleadingly imply benefits beyond physical weight loss, such as emotional relief, reduced psychological burden, hope, or direction for patients' lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition, when this has also not been demonstrated," it continues.

The reprimand comes as Novo Nordisk is looking to rapid uptake of the Wegovy pill to help steady its GLP-1 agonist business, currently facing stiff competition from Eli Lilly and its dual GLP-1/GIP agonist Zepbound (tirzepatide) as well as copycat versions of semaglutide made by compounding pharmacies.

The oral formulation seems to have started well, with over 18,000 prescriptions filled in the first full week it was available and 170,000 people taking the drug as of the first week of February. Novo Nordisk was rocked last week when telehealth company Hims & Hers started offering a compounded version of the pill.

That proved short-lived, however, as the FDA pushed back and Novo Nordisk filed a lawsuit seeking an injunction and damages. Still, competition is looking as Lilly waits for an FDA verdict on its oral GLP-1 drug, orforglipron, which is due in the second quarter.

"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 Nordisk's head of US media and stakeholder relations. A different, celebrity-packed ad ran during the Super Bowl last Sunday.