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# FDA Cites 2 Argenx TV ads for Vyvgart Hytrulo
- URL: https://www.fdaweb.com/fda-cites-2-argenx-tv-ads-for-vyvgart-hytrulo/
- Published: 2026-02-09T12:00:00.000Z
- Updated: 2026-09-14T15:32:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160626

FDA has issued two enforcement “untitled” letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo violate federal drug promotion rules by overstating benefits, minimizing risks and misleading viewers about how the drug is used. In letters sent by CDER’s Office of Prescription Drug Promotion (OPDP), the agency said both ads misbrand Vyvgart Hytrulo — approved for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) — and render its distribution violative of the Federal Food, Drug, and Cosmetic Act.

In [one letter](https://www.fda.gov/media/191010/download?attachment&ref=fdaweb.com), FDA said an ad portraying CIDP patients golfing, driving and socializing creates the misleading impression that patients treated with Vyvgart Hytrulo can broadly expect to remain highly functional with little or no limitation in daily activities. The agency said those implications are not supported by the drug’s clinical data, noting that the pivotal study measured time to clinical deterioration, not improvements in physical function or lifestyle. While the trial showed that Vyvgart Hytrulo significantly delayed disease worsening compared with placebo, FDA said the data do not demonstrate that patients can expect the level of activity depicted.

The FDA also objected to a claim stating that the “risk of arm and leg symptoms getting worse was 61% lower” with Vyvgart Hytrulo, calling it misleading. The agency said the figure was based on a hazard ratio, which reflects relative rates over time rather than absolute risk reduction, and overstated the clinical meaning of the findings.

The [other letter](https://www.fda.gov/media/191009/download?attachment&ref=fdaweb.com) faulted Argenx for oversimplifying the administration of Vyvgart Hytrulo in the DTC ad for the once-weekly subcutaneous injection. It suggested the drug could be administered in “about 30 seconds,” even while patients were engaged in activities and depictred patients injecting the drug while traveling, attending sporting events or spending weekends away from home.

OPDP said these portrayals are misleading because they fail to reflect the multiple preparation and safety steps required under the drug’s FDA-approved Instructions for Use, including allowing the medication to reach room temperature, gathering supplies, proper injection technique and post-injection monitoring.

The agency also said both ads omit or inadequately present material risk information, including warnings about allergic reactions and infusion- or injection-related reactions such as low blood pressure, breathing difficulty, and chest or back pain.

In addition, FDA said fast-paced visuals, scene changes and prominent imagery during the presentation of the required “major statement” interfered with viewers’ ability to comprehend the safety information.

In both letters, the agency requested that Argenx immediately cease dissemination of the cited promotional materials and submit a written response within 15 working days detailing corrective actions and plans to discontinue similar communications.