FDA Says Novo's Wegovy Pill TV Advertisement Is Misleading: NVO Stock Pares Gains

• The FDA stated that the totality of the claims made by Novo in the ad misleadingly suggests that, because of its pill form, Wegovy offers an advancement or improvement over other currently approved GLP-1 treatments for weight loss.
• The agency pointed to terms such as “live lighter” and “a way forward” to argue that the Novo advertisement misleadingly implies greater weight loss than other currently approved GLP-1 treatments.
• The FDA has sought a reply from Novo within 15 working days from the date of receipt.

A television advertisement by Novo Nordisk A/S (NVO) for its obesity pill Wegovy has been flagged as “misleading” by the U.S. Food and Drug Administration (FDA).

According to an FDA letter dated February 5, the agency stated that the advertisement “misbrands” Wegovy. It added that this violates the distribution provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Novo shares were up more than 8% in Monday’s opening trade, but pared some of the gains to hover nearly 4% higher at the time of writing. Retail sentiment around the NVO stock trended in the ‘bullish’ territory on the platform.

What Is The FDA Objecting To?

The FDA stated that the totality of the claims made by Novo in the TV advertisement misleadingly suggests that, because of its pill form, Wegovy offers an advancement or improvement over other currently approved GLP-1 treatments for weight loss.

“Specifically, these claims and presentations misleadingly imply that Wegovy in pill form uniquely enables patients to achieve outcomes that were not previously possible with other GLP-1 treatments for weight loss,” the FDA stated in its letter.

In particular, the agency pointed to terms such as “live lighter” and “a way forward” to argue that the Novo advertisement misleadingly implies greater weight loss than other currently approved GLP-1 treatments, even though this has not yet been demonstrated.

Beyond this, the FDA stated that the advertisement implies additional benefits such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the pill as a solution to broader life problems rather than just a specific physical condition.

The agency has sought a reply from Novo within 15 working days of receipt.

Novo’s Legal Battle With Hims & Hers

The FDA letter comes amid Novo’s legal battle with Hims & Hers Health Inc. (HIMS). The Wegovy-maker sued Hims & Hers, calling for a permanent ban on the company’s sales of unapproved, compounded drugs that infringe its patents.

“Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process,” the company said.

Last week, the FDA warned of a crackdown last week on GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs.

NVO stock is down 4% year-to-date and 43% over the past 12 months.

Also See: Momentus Partners With NASA For In-Orbit Servicing, Space Operations — MNTS Stock Rises

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