Sanofi and Regeneron’s Dupixent is already approved to treat eczema in kids as young as 6 years old—and it’s well on its way to becoming a $10 billion drug. Armed with a trial win in even younger children and infants, the antibody med could soon get another boost.
Dupixent plus standard of care topical corticosteroids “significantly” trumped placebo at improving skin clearance and curbing overall disease severity and itch in patients ages 6 months to 5 years with uncontrolled, moderate-to-severe atopic dermatitis, results from the drug’s phase 3 Liberty Ad Preschool trial show.
Sanofi already said in August that Dupixent smashed all primary and secondary endpoints in the 162-patient trial. In data unveiled during a late-breaking session at the 2021 Revolutionizing Atopic Dermatitis Conference (RAD 2021), the French drugmaker unveiled just how well the med performed.
RELATED: November sees Sanofi-Regeneron dethroned after 6-month rule over TV ad spender list
In the trial, 28% of patients on the Dupixent-corticosteroid combo achieved clear or almost-clear skin at week 16, versus 4% in the placebo group. Those results were good enough for the trial to meet its primary endpoint.
Over that same time period, 53% of Dupixent patients hit 75% or greater improvement in overall disease severity from baseline, versus 11% in the control group. This was the co-primary endpoint outside the U.S.
Patients in the Dupixent group experienced a 49% average improvement in itch from baseline, versus 2% in the placebo cohort. Patients on Dupixent experienced 70% average improvement from baseline in overall disease severity, versus 20% improvement with placebo.
Sanofi and Regeneron will use the data to pursue a Dupixent approval in kids ages 6-months to 5-years, starting with the U.S. in 2021 and the European Union in the first half of 2022, the companies said in a release. Dupixent is the first biologic to demonstrate positive results in this young of a patient population, Sanofi said.
Safety in the trial was on par with Dupixent in older kids, adolescents and adults, Sanofi said. There was an overall side effect rate of 64% in the Dupixent arm versus 74% in the control.
RELATED: Surprise COVID-19 antibody sales of $804M help Regeneron trounce expectations in third quarter
Dupixent’s star is rising. The drug’s sales climbed 55% in the third quarter to $1.66 billion worldwide, versus about $1.07 billion during the same period in 2020, Regeneron reported last month. Over the first nine months of the year, Dupixent reaped about $4.42 billion globally, compared to $2.87 billion for the period in 2020.
Sanofi executives earlier this year predicted that Dupixent, flush with strong data in five different diseases, could eventually snare €10 billion annually. That’s about double what the monoclonal antibody is making now.
Meanwhile, prospects for label expansions are bright, thanks to positive data in chronic spontaneous urticaria, prurigo nodularis and eosinophilic esophagitis, as well as atopic dermatitis in infants and young kids, Sanofi execs have said.