Sanofi and Regeneron’s biologic Dupixent has been granted a priority review in the US for use to treat certain adolescent patients with moderate-to-severe atopic dermatitis.
The companies are seeking approval to market the drug for patients aged 12 to 17 years whose disease is inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.
Dupixent (dupilumab) inhibits interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, two key drivers of Type 2 inflammation, a systemic response known to play a role in moderate-to-severe atopic dermatitis.
In one clinical trial, 24% of patients who received weight-based dosing of Dupixent every two weeks and 18% of those given a fixed dose every four weeks achieved the primary endpoint of clear or almost-clear skin, versus 2% in the placebo arm.
Also, 41.5% of those who received Dupixent every two weeks and 38 percent of patients who took the drug every four weeks achieved 75% or greater skin improvement (EASI-75) compared to 8% in the control group.
On the safety side, the overall rate of adverse events was comparable between the Dupixent groups and placebo (72% for Dupixent every two weeks, 64% for Dupixent every four weeks and 69% for placebo) over the 16-week treatment period, while there were no serious adverse events or events leading to treatment discontinuation in either drug treatment group.
Dupixent was approved in the US in March last year for the treatment of adults with moderate-to-severe atopic dermatitis, and just days ago won clearance for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Its approval for adolescents with moderate-to-severe atopic dermatitis could help address significant unmet medical need for this patient group, who have no approved systemic biologic medications.
A decision by the US Food and Drug Administration is expected by March 11, 2019.