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Feb 9 (Reuters) - The U.S. Food and Drug Administration said a television advertisement for Novo Nordisk's weight-loss pill is "false or misleading," according to a letter dated February 5.
The health regulator said the television spot misleadingly suggests that Wegovy, in its pill form, offers an advancement or improvement over other weight-loss drugs that belong to the class known as GLP-1s.
"We confirm that Novo Nordisk received an 'Untitled Letter' from FDA concerning a television commercial for Wegovy pill, which has been running since launch — not the Super Bowl ad," said Novo spokeswoman Ambre James-Brown.
The agency said the Novo direct-to-consumer ad was in violation of the Federal Food, Drug, and Cosmetic Act, and asked the drugmaker to take immediate action to address any violations, which could include ceasing all ads containing misleading claims.
"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," James-Brown added.
The FDA also said 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.
"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," the agency said in the letter.
The FDA also flagged the ad included certain presentations where the text on screen did not match the audio.
(Reporting by Sriparna Roy in Bengaluru; Editing by Vijay Kishore and Alan Barona)
