AbbVie faulted for misleading ad featuring Serena Williams

Pharma giant AbbVie has been taken to task by the FDA for running an ad for one of its migraine drugs, featuring tennis star Serena Williams, which the agency says overstates its efficacy.

In the ad for oral CGRP inhibitor Ubrelvy (ubrogepant), Williams is depicted as suffering from a migraine while in a talk show dressing room, which resolves by the time she walks onto the set and allows her to carry out the interview laughing and pain-free.

A voiceover by the star – who has become something of an advocate for migraineurs since revealing she suffers from them several years ago – remarks: "When migraine strikes, you're faced with a choice. Ride it out with the trade-offs or treating? Or push through the pain and symptoms?"

She continues: "With Ubrelvy, there's another option. One dose works fast to eliminate migraine pain."

The FDA has called out that statement, saying in its letter that the ad gives no indication of how long it takes Ubrelvy to work and makes "false or misleading representations" about the drug.

The implication is 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," according to the regulator. "Healthcare providers, patients, and caregivers should not be misled regarding the benefits that can be expected from acute migraine headache treatments."

This is actually a double fault for Ubrelvy advertising in the US, as the FDA previously sent a letter upbraiding Allergan – which was acquired by AbbVie for $63 billion – five years ago, shortly before the takeover went through in 2020. Williams started promoting the drug in the same year.

The FDA says that it is "concerned that AbbVie […] appears to be promoting Ubrelvy using similar claims and presentations in a misleading manner," and asks the drugmaker to stop running the ad immediately or cease Ubrelvy distribution.

The latter isn't going to happen of course. AbbVie recorded sales of more than $1.2 billion for Ubrelvy and partner migraine drug Qulipta for episodic and chronic migraine prevention last year.

AbbVie told Stat that it had stopped airing the ad after the first half of the year and that it is complying with the FDA's investigation.

So-called 'untitled letters' from the FDA for advertising breaches are fairly uncommon, with only four sent so far this year.

Previous warnings were delivered to Novartis for promotion of breast cancer therapy Kisqali (ribociclib), as well as to Kaleo for its epinephrine drug Auvi-Q, and Bristol-Myers Squibb's lung cancer medicine Krazati (adagrasib).