The FDA has just written a letter to pharma-giant AbbVie, asking the company to cease running an advertisement for a migraine drug that features tennis legend Serena Williams.
The letter details that the advertisement for Ubrelvy ‘makes false or misleading representations’ about the drug, and might lead migraine patients to believe that, ‘all patients who take Ubrelvy can expect their migraine pain to be eliminated after a single dose of Ubrelvy, when this has not been demonstrated’.
It asks the company to come up with a plan to cease running the advertisement or discontinue distribution of the drug.
AbbVie reported that sales from Ubrelvy and a similar migraine medication called Qulipta, generated $1.223billion in revenue for the company in 2023.
This is the second time the FDA has warned a pharmaceutical company about Ubrelvy advertisement. Before Ubrelvy was owned by AbbVie, it was owned by Allergan, which was acquired by AbbVie in 2019
Serena Williams attends day seven of the 2024 US Open Tennis Championships in New York. The tennis star has shared previously that she suffers with migraines and takes prescription medications to deal with them
This is not the first time the agency has raised concerns about advertising Ubrelvy. The company that originally promoted the drug, Allergen, was hit with a similiar letter before they were acquired by AbbVie in 2019.
Ms Williams, who has won more Grand Slam single titles than any player in the Open area, has shared previously that she suffers from migraines. In
The tennis legend told People in 2021 that her migraines became debilitating during the pandemic, and that found relief in the medication, which must be prescribed by a doctor.
Ubrelvy is taken as a 50 or 100 mg pill. The cost of the drug without insurance would be around $1,000 for ten tablets, but could be less with rebates from AbbVie or insurance coverage. With insurance, Amazon lists the drug price at $35.
Similiar drugs include Nurtec, Ajovy, Emgality and Aimovig – which are all manufactured by different companies.
A study earlier this year suggested that taking the pill before a migraine sets in helped 65 percent of people prevent migraine.
Though these might be encouraging results for the 39million Americans who suffer with migraine – the drug wasn’t a panacea. It did not work for all of the 518 patients who participated in the trial, which was published in the journal Neurology.
Despite this, the FDA letter stated, the advertisement made it seem like the drug will work for every patient who takes it.
It said: ‘These violations are concerning from a public health perspective because the TV ad, featuring Serena Williams, misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.’
Overall, these kinds of letters are rare – the FDA has only issued four thus far in 2024.
AbbVie told Bloomberg News that they had stopped airing the advertisement after the first half of the year, and that it is complying with the FDA’s investigation.
***
Read more at DailyMail.co.uk