A U.S. advertising self-regulatory body has told Galderma to drop or change a claim about how quickly Nemluvio provides itch relief, triggered by a complaint from competitor Sanofi.
Nemluvio is approved for use in patients with moderate to severe atopic dermatitis or prurigo nodularis. According to the case report from the BBB National Programs’ National Advertising Division (NAD), on webpages and social media, Galderma promoted the drug as providing “instantaneous itch relief.” The company also said Nemluvio provides itch relief in “as soon as 48 hours” and used the tagline “itch relief like that” alongside an image of a woman snapping her fingers.
Sanofi, which sells Dupixent for use against atopic dermatitis and prurigo nodularis, challenged the claims, sparking an investigation by the NAD.
The NAD ultimately found that the post hoc analyses Galderma used to support its claims were reliable and that there was no need for the company to explain the purported limitations of the analyses in the challenged ads. But the watchdog did take issue with one of the claims itself: the “as soon as 48 hours“ promo, which the NAD said is “functionally equivalent“ to a claim of itch relief in “up to“ 48 hours and so would need to be backed by data showing that “an appreciable number“ of patients achieved the benefit.
Per Galderma’s data, only 6% to 13% of patients, depending on the indication, experienced significant itch relief within 48 hours after netting control results. Galderma’s disclosures about the proportion of patients who received itch relief within 48 hours “were inconspicuous and would be difficult for ordinary consumers to decipher,” the NAD said.
That finding led the self-regulatory body to recommend that Galderma drop or modify its “as soon as 48 hours” claims.
Modifying the claim entails disclosing “clearly, conspicuously and in close proximity” either the percentages of people with 48-hour itch relief in the treatment and control arms or the placebo-adjusted result, the NAD said. Claims made in the audio portion of an ad would need to be balanced by clear and conspicuous audio about the 48-hour response rates.
Galderma agreed voluntarily during the investigation to permanently stop using the finger-snap imagery with the “itch relief like that” statement in ads for consumers. The company said it will comply with the NAD’s recommendations for its Nemluvio promotions, according to the case report.