FRANCE – As a stable of new players sets out to topple Dupixent’s status as the reigning antibody treatment for atopic dermatitis, the blockbuster’s developers are moving the goalposts.

Dupixent has aced a Phase III trial involving 162 children between 6 months and 5 years old, Sanofi and Regeneron say, becoming the first biologic drug to show efficacy in this young population.

When given Dupixent on top of standard of care topical corticosteroids, 28% of patients achieved clear or almost-clear skin compared to 4% of those on placebo — thus meeting the primary endpoint.

Sanofi and Regeneron have bet big on the Dupixent franchise, and analysts have largely expected it to pay off, with Jefferies once pegging peak sales at US$12.5 billion.

Core to the pitch for physicians will be the fact that even as it clears eczema, the drug doesn’t broadly suppress the immune system, which could be particularly dangerous for young infants.

“When a child is diagnosed with moderate-to-severe atopic dermatitis in the first few months of life, many aspects of their childhood can be significantly impacted. Parents and caregivers are challenged to find safe and effective treatment options,” said John Reed, Sanofi’s head of R&D.

“Currently, the standard of care for this patient population is topical steroids and other immunosuppressive medicines may be used which can damage delicate skin and, if used long-term, potentially impact growth.”

The drug, which is already approved for children aged 6 or above, also met the co-primary endpoint outside of the US, which is 75% or greater overall disease improvement from baseline.

Investigators also spelled out stellar numbers on a handful of secondary endpoints, in addition to “significantly improved measures” in symptoms such as sleep, skin pain and other quality of life metrics.

During the 16-week treatment period, the companies added, patients on Dupixent were 50% less likely to get a skin infection — 12% of them did (or 11 infections), compared to 24% on placebo (or 34 infections).

Eli Lilly, Pfizer, Amgen and others are hot in pursuit of the drug as they seek a slice of the eczema market for themselves, but they will first have to crash a solid wall of data that Sanofi and Regeneron continue to build.

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