Sanofi unveils eczema drug data, as regulators mull label expansion
Sanofi has revealed details of research, which forms the basis of filings to extend the use of its eczema drug Dupixent (dupilumab) so it can be used to treat adolescents.
Phase 3 trials of the targeted biologic medicine, which was tested on patients aged 12-17 who had moderate to severe atopic dermatitis, were positive.
The results from this trial in adolescents form the basis of regulatory submissions for patients in this younger age group.
The drug is currently approved for use in certain adult patients with moderate-to-severe atopic dermatitis in countries including the US, European Union, Canada and Japan.
Data revealed at the recent European Academy of Dermatology and Venereology conference showed that the monotherapy demonstrated a significant improvement in the signs and symptoms of atopic dermatitis as well as enhancing patients’ quality of life.
The drug is aimed at those for whom topical treatments either do not work well or who cannot use such treatments for medical reasons. It is the first biologic therapy for atopic dermatitis.
The trial showed that 41.5% of patients aged 12-17 who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks achieved 75% or greater skin improvement according to the Eczema Area and Severity Index (EASI) compared to 8% treated with a placebo.
Nearly one in four patients who received weight-based dosing of Dupixent every two weeks (200mg or 300mg) and 18% of patients who received a fixed dose of Dupixent every four weeks (300mg) achieved the primary endpoint of having clear or almost-clear skin, compared with 2% if treated with a placebo.
Amy Paller, director of the Northwestern University Skin Disease Research Center and principal investigator of the trial, said: “Limited treatment options leave adolescents with uncontrolled moderate-to-severe atopic dermatitis to cope with intense, unrelenting itch and skin lesions.
“The results … show the potential for Dupixent in adolescents to not only help clear the skin and reduce itching, but also improve certain aspects of quality of life in adolescents who may be dealing with these unbearable symptoms.”
Dupixent, which is administered by injection, inhibits interleukin-4 and interleukin-13 (IL-4 and IL-13), which are major contributors to type 2 inflammation, a systemic, allergic response known to play a role in moderate-to-severe atopic dermatitis – the scientific name for eczema.
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