Sanofi, Regeneron's Dupixent aces late-stage study in young children with atopic dermatitis

Dupixent’s promising readout in young children is noteworthy given that current immunosuppressive and topical steroid treatments can damage delicate skin and may impact growth in the long run, the drugmakers said. (Sanofi)

Just as JAK rivals look to gain on Sanofi and Regeneron’s atopic dermatitis med Dupixent, the pair are touting new trial results that could keep their blockbuster drug ahead of the pack. 

Dupixent met all of its goals in a phase 3 trial studying the treatment in children aged 6 months to 5 years old with moderate-to-severe atopic dermatitis, making it the only biologic drug with positive data in patients that young, the companies said.

Specifically, the 162-child study found that Dupixent paired with standard of care, low-potency topical corticosteroids (TCS), reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to just TCS alone, the pair said. 

Of the kids using the Dupixent-TCS combo, 28% reported clear or almost clear skin compared with just 4% of those using only TCS, Sanofi and Regeneron said.

Meanwhile, just over half of patients experienced at least a 75% disease improvement from when they started treatment on Dupixent. That compared with just 11% of patients who received TCS, meeting the trial’s primary endpoints. No new safety concerns were reported. 

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To the companies, Dupixent’s promising results in children are noteworthy given that current immunosuppressive and topical steroid treatments can damage delicate skin and may impact growth in the long run. 

Dupixent is currently FDA approved for kids as young as 6 years old. Sanofi and Regeneron will present their latest findings with regulators, they said.

Dupixent’s readout in young atopic dermatitis patients comes just as its rivals look to knock the monoclonal antibody off course. Pfizer posted its own Dupixent-topping data on Monday, saying its oral JAK1 inhibitor abrocitinib outperformed Sanofi and Regeneron’s med when studied in adults with moderate to severe atopic dermatitis. Pfizer didn’t include key safety data in its update.

The entire class of JAK inhibitors has come under intense scrutiny from the FDA in recent months after Pfizer’s Xeljanz, also known as tofacitinib, was linked to an increased risk of cardiovascular events and cancer. 

That’s bought Dupixent extra time as regulators repeatedly push back their decisions for a number of up and comers. As for Sanofi, executives think Dupixent is just at the start of its journey. 

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With its latest late-stage results in moderate-to-severe chronic spontaneous urticaria, the French pharma now has positive key Dupixent data in five different diseases. The company projects its Regeneron-partnered drug could eventually rake in €10 billion annually, roughly double what it’s currently bringing in now, executives said on an earnings call in late July.