Lundbeck’s online promotion of migraine med Vyepti has caught the attention of the FDA, with the agency inking an untitled letter that calls out the company for potentially misleading efficacy claims.
In the letter (PDF), the FDA takes issue with several of Vyepti’s efficacy and two-year patient outcomes listed on its healthcare provider webpage, noting “several significant limitations” to the clinical studies referenced which ultimately “preclude the drawing of conclusory claims” regarding the drug’s benefits.
For one, Lundbeck’s webpage said that in a six-month chronic migraine study, "40% of patients treated with Vyepti 300mg were 100% migraine free for a month or more vs 22% with placebo.” This was accompanied by a graphic of a woman standing in front of a large 100% image, the FDA points out. Other phrases on the webpage such as “give your patients the chance for 100% migraine freedom for a month or more,” were also cited in the untitled letter.
The data mentioned comes from a post-hoc analysis of Lundbeck’s Promise-1 and Promise-2 studies. However, the agency finds these findings “exploratory,” as the analyses were conducted after the trial and without a prespecified statistical procedure to control for a false positive rate, meaning “it is not possible to ascertain whether the findings were attributable to treatment with Vyepti, or merely due to chance,” the FDA wrote.
The agency further challenges other claims on the webpage that attribute Vyepti to “sustained reduction” in pain severity, “much improved” or “very much improved” symptoms and other similar promotions.
This, the FDA says, creates a “misleading impression” that the drug proved beneficial in patient-reported outcomes, but these outcomes also didn’t have a specified false positive error rate. Therefore it is “not known whether the outcomes data were due to chance,” the FDA wrote.
Additionally, the study based its patient-reported outcomes on the Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS). HIT-6 is not specific to migraines and therefore lacks “content validity” for migraines, while MIDAS has some limitations as well and is “prone to recall bias” and errors, according to the FDA.
Finally, Lundbeck uses “attention-grabbing, colorful, bold graphics” and large-font charts to promote additional Vyepti claims on a patient experience webpage, which emphasizes patients’ increased satisfaction with their ability to “plan, be productive and participate in their daily lives” upon using Vyepti, plus improvement in brain fog and an increase in the amount of “monthly good days.”
However, the real-world effectiveness study which this data is from holds “inherent selection bias” due to the study criteria including only patients who have completed two or more consecutive Vyepti infusion cycles, which “may have created a favorable bias," the agency wrote. Additionally, terms such as “good days” and “brain fog” can be linked to “interpretational limitations” as the terms don’t have standardized definitions and may be swayed by unrelated confounding factors "rather than true clinical benefits," FDA officials explained in the letter.
Lundbeck maintains a "high standard for our work in providing complete, accurate, and balanced information, and we remain committed to responding thoroughly to the concerns raised by the FDA,” a company spokesperson told Fierce Pharma Marketing in an emailed statement. “We are carefully reviewing the FDA untitled letter in response to data presented on the Vyepti healthcare provider website and are preparing a written response within the required timeframe.”
The FDA requested that the company takes “immediate action” to address the violations and submit a written response to the letter within 15 working days, explaining its plan for "the discontinuation of such communications, or for ceasing distribution of Vyepti.”
2020-approved Vyepti helped Lundbeck deliver a “record performance” in 2025, with full year sales of the drug hitting 4.47 billion Danish kroner ($683 million) over the year in 59% growth as the “fastest-growing” CGRP product in the U.S., Lundbeck has said.
The drugmaker’s top-selling drug, however, remains Otsuka-partnered atypical antipsychotic Rexulti, which in 2023 was also the target of an FDA untitled letter based on claims related to its major depressive disorder indication.