Galderma Laboratories has landed a significant blow against Sanofi in an ongoing multi-case advertising dispute over their rival eczema treatments.
The BBB National Programs’ National Advertising Division ruled that Sanofi must change or drop certain claims about its blockbuster biologic medicine Dupixent following a challenge by Galderma.
The NAD recommended that Sanofi modify or discontinue television claims linking Dupixent to long-lasting clearer skin and fast itch relief for patients.
The U.S. advertising self-regulatory body also advised Sanofi to change or drop a prescriber-facing claim that Dupixent provided itch relief as early as Day 2.
Galderma had challenged claims about Dupixent’s mechanism of action, ability to address inflammation, capacity to heal skin from within, and overall efficacy against eczema.
The NAD determined that Sanofi’s evidence supports a properly qualified claim that some adults achieved long-lasting clearer skin at four months and at one year.
The regulator also found that some patients saw fast itch relief after the first dose at two weeks, but required clearer disclosure of how many patients achieved those advertised results.
NAD further recommended modifying claims where results reflected treatment with Dupixent used in combination with topical corticosteroids, which was not always made conspicuous to consumers.
On the Day 2 itch relief claim, the NAD found that the post hoc analysis underpinning it failed to support a message that Dupixent demonstrated a meaningful treatment benefit beginning that early.
The NAD did, however, find support for claims that Dupixent helps patients “stay ahead of eczema,” blocks “a key source of inflammation,” and can “help heal your skin from within.”
Regulators also concluded that Sanofi’s advertising did not convey the implied message that Dupixent is superior to all other FDA-approved eczema treatments on the market.
The NAD determined that the challenged advertising did not convey implied messages alleged by Galderma that Dupixent prevents eczema progression or promises complete healing of eczema-related skin lesions.
Sanofi is permitted to continue making its 90% clearer skin claim, though the NAD recommended against overstating supporting evidence or obscuring the treatment context surrounding those results.
The ruling comes after the NAD had previously ruled against Galderma in two separate cases brought by Sanofi last year, recommending that Galderma change or drop certain claims about its own IL-31 drug Nemluvio.
Both Galderma and Sanofi market FDA-approved biologic treatments for moderate-to-severe eczema, including for prurigo nodularis, placing them in direct commercial competition across multiple indications.
In its advertiser statement, Sanofi said that it “will comply with NAD’s recommendations,” signalling a resolution to this particular phase of the broader advertising dispute between the two pharmaceutical rivals.