National Advertising Division Finds Certain Nemluvio Claims Supported; Recommends Galderma Modify or Discontinue "As Soon as 48 Hours" Claims

In a challenge brought by competitor Sanofi, BBB National Programs’ National Advertising Division found certain Galderma Laboratories, L.P. itch relief claims supported, but recommended that Galderma modify or discontinue claims that its drug, Nemluvio, provides itch relief “as soon as 48 hours” for patients with moderate-to-severe atopic dermatitis (eczema) or prurigo nodularis (PN).

New York, NY, Oct. 07, 2025 (GLOBE NEWSWIRE) -- In a challenge brought by competitor Sanofi, BBB National Programs’ National Advertising Division found certain Galderma Laboratories, L.P. itch relief claims supported, but recommended that Galderma modify or discontinue claims that its drug, Nemluvio, provides itch relief “as soon as 48 hours” for patients with moderate-to-severe atopic dermatitis (eczema) or prurigo nodularis (PN).

Sanofi and Galderma are competitors in the pharmaceutical space. Galderma’s Nemluvio is a monoclonal antibody approved by the FDA to treat adults with PN, and to treat moderate-to-severe eczema in those 12 years of age and older when used in combination with topical therapies.

At issue for the National Advertising Division (NAD) was whether express and implied claims on webpages and in social media communicated “instantaneous itch relief,” the appropriateness of Galderma’s reliance upon post hoc analyses to support its “as soon as 48 hours” itch relief claims, and whether appreciable numbers of patients obtain itch relief as quickly as claimed.

Instantaneous Itch Relief Claims

On webpages directed to health care professionals (HCPs), under language about Nemluvio being approved for adults and adolescents with eczema or being approved for adults with PN, was the headline “Itch relief like that” together with an image of a woman snapping her fingers.

NAD determined that the qualifying statement “A novel, IL-31RA-targeted biologic that

delivers itch relief as soon as 48 hours” under the image was clear, conspicuous, and reasonably close to the headline, adequately limiting the fast-itch-relief message. NAD also found that the webpages did not communicate an instantaneous itch relief claim.

In addition, NAD evaluated a survey submitted by Galderma of 300 dermatologists, half seeing the test ad and half a control ad with the headline changed to “Itch relief as soon as 48 hours.” No more than 3.3% of those seeing the test ad and 1.3% of those seeing the control ad interpreted the message as instantaneous. NAD determined the survey was reliable and showed that dermatologists did not take away an implied claim of instantaneous itch relief from the eczema-focused HCP ad.

“As Soon as 48 Hours” Claims

NAD reviewed the express “as soon as 48 hours” claims on the HCP webpages and one directed to consumers and found that the ads conveyed the message that Nemluvio provides itch relief within 48 hours from treatment to appreciable numbers of eczema and PN patients.

NAD also found that the disclosures about study results, which refer to a “Phase 3 clinical study,” conveyed the message that the 48-hour itch relief claims were clinically proven and that Nemluvio advertising communicated that the within-48-hours-from-treatment claims were clinically proven.

After reviewing the evidence, NAD determined that Galderma’s post hoc analyses were reliable and that Galderma did not need to explain the purported limitations of those analyses in the challenged advertising. NAD determined, however, that unqualified “as soon as 48 hours” claims were not supported, as only 6% of eczema patients and 13% of PN patients achieved significant itch relief in 48 hours after netting control results. An “as soon as” claim is functionally equivalent to an “up to” claim and requires that an appreciable number of consumers obtain the stated benefit.

NAD found that Galderma’s disclosures regarding the incidence of 48-hour relief were inconspicuous and would be difficult for ordinary consumers to decipher. Therefore, NAD recommended that Galderma discontinue or modify “as soon as 48 hours” claims by disclosing clearly, conspicuously, and in close proximity either the percentages of patients obtaining 48-hour itch relief in the treatment and placebo groups or the percentage after netting the placebo. If such claims are made in the audio portion of an ad, the disclosure would need to be made in the audio portion to be clear and conspicuous.

During the proceeding, Galderma voluntarily agreed to permanently discontinue using the finger-snap imagery with the “Itch Relief Like That” statement in advertising directed to consumers. NAD will treat these claims, for compliance purposes, as though NAD recommended they be discontinued.

In its advertiser’s statement, Galderma stated it “will comply with NAD’s recommendations regarding Nemluvio advertising.”

All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. Pursuant to NAD/NARB Procedures, this release may not be used for promotional purposes.

About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than 20 globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create fair competition for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.

About the National Advertising Division: The National Advertising Division of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. The National Advertising Division reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and creating fair competition for business.

Name: Jennifer Rosenberg
Email: jrosenberg@bbbnp.org
Job Title: media relations

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