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# FDA Cites Lundbeck Over Vyepti Promotional Claims
- URL: https://www.fdaweb.com/fda-cites-lundbeck-over-vyepti-promotional-claims/
- Published: 2026-07-07T12:00:00.000Z
- Updated: 2026-09-14T13:42:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161418

FDA has issued Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyepti (eptinezumab-jjmr) make unsupported efficacy and patient-reported outcome claims based on exploratory analyses and uncontrolled studies.

The CDER Office of Prescription Drug Promotion (OPDP) [letter ](https://www.fda.gov/media/193472/download?attachment&ref=fdaweb.com)targets two Web pages on Vyepti's healthcare professional Web site that promote the drug's efficacy and long-term patient outcomes. FDA concluded that the materials are "false or misleading," resulting in the misbranding of Vyepti under the Federal Food, Drug, and Cosmetic Act.

At the center of the agency's concerns are claims suggesting that patients treated with Vyepti could achieve complete migraine freedom for a month or longer, as well as improvements in migraine severity, disability, productivity, quality of life, and cognitive symptoms such as "brain fog."

FDA said the promotional claims rely heavily on post-hoc analyses of the PROMISE clinical trials and findings from PREVAIL, a long-term, open-label, single-arm extension study, neither of which adequately support definitive conclusions about the drug's benefits.

Among the claims cited by FDA were statements that 40% of patients receiving the 300 mg dose of Vyepti were "100% migraine free for a month or more," accompanied by marketing language encouraging physicians to "Give your patients the chance for 100% migraine freedom for a month or more."

According to the agency, those claims are based on post-hoc analyses that did not include prespecified statistical controls for Type I error, making the findings exploratory rather than confirmatory.

Because the analyses were conducted after completion of the original trials, FDA said it cannot determine whether the observed results were attributable to treatment or occurred by chance. The agency noted that simply identifying the analyses as "post hoc" in a footnote does not adequately mitigate the misleading impression created by the promotional materials.

FDA also challenged claims that Vyepti produces sustained improvements in headache severity, migraine-related disability, productivity, and overall quality of life over two years.

The agency said those conclusions were drawn from patient-reported outcome (PRO) measures collected during the PREVAIL study, which lacked a control group and did not allocate statistical significance testing to those endpoints.

Without prespecified statistical controls, FDA said the results should be considered hypothesis-generating rather than evidence of established clinical benefit.

The agency further questioned the validity of several assessment instruments used in the study, including the Headache Impact Test, the Migraine Disability Assessment, and the Patient Global Impression of Change, citing concerns about recall bias, lack of migraine-specific validation, and limitations inherent in patient self-reporting over extended periods.

A second promotional Web page highlighted results from the observational REVIEW study, which reported improvements in patient satisfaction, "good days," and "brain fog" after treatment with Vyepti. FDA said those claims likewise overstate the evidence.

According to the agency, the study enrolled only patients who had already completed at least two consecutive Vyepti infusion cycles, creating substantial selection bias by excluding patients who discontinued treatment because of lack of efficacy or adverse events.

The agency also criticized the study's reliance on subjective endpoints that lack standardized definitions or validated measurement tools, including "good days" and "brain fog." FDA said the absence of an active control group makes it impossible to determine whether reported improvements resulted from treatment rather than patient expectations, recall bias, or other confounding factors.

The letter underscores OPDP's continued focus on ensuring promotional claims are supported by substantial evidence and appropriately characterize the limitations of exploratory analyses, open-label studies, and real-world evidence.

Additionally, the letter is noteworthy because it is one of OPDP's more detailed critiques of the promotional use of PROs and real-world evidence (RWE). Rather than focusing on traditional risk-benefit balance, FDA devotes much of the letter to explaining why exploratory analyses, open-label studies, observational research, and subjective endpoints such as "brain fog" and "good days" are insufficient to support promotional claims. That emphasis could signal heightened scrutiny of companies' increasing reliance on RWE and PRO data in healthcare professional marketing.