FDA grants priority review status for Dupixent in atopic dermatitis

Sanofi and Regeneron Pharmaceuticals have received priority review status from the US Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis.

Dupixent is designed to block interleukin-4 and interleukin-13 (IL-4 and IL-13) signalling associated with type 2 inflammation, which is involved in moderate-to-severe atopic dermatitis.

The FDA previously approved the drug for treatment of moderate-to-severe atopic dermatitis in adults.

Dupixent also holds approvals for certain adult patients with moderate-to-severe atopic dermatitis in the European Union countries, Canada and Japan, among others.

The sBLA seeks approval for patients aged 12 to 17 years who did not experience adequate disease control with topical therapies or for whom topical treatment could not be prescribed.

It includes results from a pivotal Phase III clinical trial designed to assess the efficacy and safety of Dupixent as a monotherapy in 251 adolescent patients with moderate-to-severe atopic dermatitis.

Director of the Northwestern University Skin Disease Research Centre and principal investigator of the trial Amy S Paller said: "Limited treatment options leave adolescents with uncontrolled moderate-to-severe atopic dermatitis to cope with intense, unrelenting itch and skin lesions."

"The results we are presenting today 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."

According to the detailed findings reported by Sanofi in September this year, 41.5% of patients treated with Dupixent every two weeks and 38% of those receiving it every four weeks achieved 75% or greater skin improvement (EASI-75), compared to 8% with placebo.

Furthermore, 24% in two weeks arm and 18% in four weeks group demonstrated clear or almost-clear skin, compared to 2% in case of placebo.

Most frequent Dupixent-related adverse events were found to be injection site reactions and conjunctivitis.

Sanofi and Regeneron are also performing additional trials to investigate the use of dupilumab in other type 2 inflammation conditions such as chronic rhinosinusitis with nasal polyps and peanut allergies.

Last month, the US regulatory authority approved the drug as an add-on maintenance treatment for moderate-to-severe asthma patients aged 12 years or older.

The partners additionally plan to assess Dupixent in chronic obstructive pulmonary disease.