In recent months, Johnson & Johnson has massively upped its spending on television advertisements for immunology heavyweight Tremfya, with the brand topping the list of the biggest TV drug ad spenders for the last two months running. One of its many on-screen promos, however, now finds itself in the FDA’s crosshairs.
An untitled letter (PDF) shared to the agency’s public database this month homes in on certain details of a commercial touting Tremfya’s use in ulcerative colitis.
Unlike most entries in the FDA’s recent spate of untitled letters, this one doesn’t take issue with “attention-grabbing visuals” that could potentially distract from important drug facts. Instead, it focuses on the ad’s claims about Tremfya’s benefits.
For one, the FDA singled out the ad’s claim in voiceover and on-screen text that “many people” or “~1 out of 2 patients” experienced clinical remission “at 1 and even 2 years.” That’s “misleading,” according to the regulator, because the one-year claims appear to be based on data from a maintenance trial comprising only the subset of patients who demonstrated a clinical response to Tremfya after 12 weeks in a pair of original trials. The two-year claim, meanwhile, is based on results from an extension trial that enrolled “a subset of that subset,” the letter said.
The agency used the same reasoning to call out another of the ad’s claims. On-screen text notes that about a third of Tremfya patients achieved endoscopic remission after a year of treatment, which the FDA said “misleadingly overstates the efficacy of Tremfya,” as it too is based on data from the maintenance trial.
The FDA called out another alleged overstatement in the ad’s claims throughout that “healing is possible” with the drug and that some patients saw “100% visible healing of their intestinal lining.”
“There is uncertainty about whether the drug effects on endoscopic endpoints will reliably predict the drug effects on long-term clinical outcomes; neither endoscopic response nor endoscopic remission guarantee a long-term curative effect or ‘healing’ for these patients,” the FDA wrote.
Though the regulator acknowledged the ad’s inclusion of the disclaimer that “visually assessed areas may not represent remission of the entire colon lining,” it dismissed that statement as insufficient for correcting or mitigating the “healing” claims.
Finally, the letter took issue with the ad’s omission of one piece of Tremfya’s risk information that warns that the drug “may lower the ability of your immune system to fight infections”—though the commercial does include the other half of that statement, about an “increased risk of infections” linked to Tremfya.
As with its other untitled letters, the FDA gave J&J 15 working days to respond to its concerns in writing. J&J did not immediately respond to a Fierce Pharma Marketing request for comment.