The U.S. Food and Drug Administration (FDA) has issued a Letter to Lundbeck Seattle Biopharmaceuticals, alleging that promotional materials for its migraine treatment Vyepti (eptinezumab-jjmr) contained false or misleading claims that overstated the drug's benefits.
According to the FDA, webpages on Vyepti's healthcare professional website suggested that patients could achieve "100% migraine freedom" for a month or more and highlighted long-term improvements in migraine severity, disability, productivity, daily functioning, and "brain fog." The agency stated that these claims relied heavily on post-hoc analyses, open-label studies, and observational research, which do not provide sufficient evidence to support definitive promotional statements.
The FDA said these presentations create a misleading impression that the benefits have been conclusively demonstrated, despite important scientific limitations such as the absence of control groups, exploratory analyses without prespecified statistical controls, and potential biases in patient-reported outcomes.
The agency concluded that the promotional webpages misbrand Vyepti under the Federal Food, Drug, and Cosmetic Act and requested Lundbeck to immediately stop or correct the misleading promotional communications. The company has been asked to submit a written response within 15 working days, outlining the corrective actions it will take and identifying any similar promotional materials currently in use.
Vyepti is an intravenous monoclonal antibody approved for the preventive treatment of migraine in adults. The FDA emphasized that promotional claims for prescription medicines must be supported by substantial evidence and accurately reflect the drug's approved labeling and clinical data.
