Biologics License Application Submitted for Atopic Dermatitis Drug

Regeneron and Sanofi recently announced that their drug, dupilumab, received priority review of its Biologic License Application.

Dupilumab is an investigational antibody treatment for patients with inadequately controlled moderate-to-severe atopic dermatitis. The drug works by inhibiting the signaling of the IL-4 and IL-3 cytokines, which are required for the immune response that is thought to be a major driver of the disease, according to Regeneron.

Patients with atopic dermatitis experience dry, itchy skin that can often become infected through scratching. While the inflammation can come and go, the recurring rash can make skin tough and thickened.

Included in the Biologic License Application are findings from three phase 3 studies of the drug. The studies were a part of the LIBERTY AD program, which analyzed the drug in more than 2500 adult patients with moderate-to-severe atopic dermatitis, whose disease is not well-controlled with topical prescription treatments.

In these studies, scientists investigated the drug as a monotherapy (SOLO 1 and SOLO 2), and in concomitant administration with corticosteroids (CHRONOS), according to Regeneron.

New findings from the SOLO 1 and SOLO 2 studies were presented at the 25th European Academy of Dermatology and Venereology Congress. The companies previously announced positive results from the CHRONS study, finding that the use of dupilumab and corticosteroids resulted in skin clearing and improvements in disease severity.

Dupilumab was granted breakthrough therapy designation in 2014 for the treatment of adults whose disease is not controlled with topical treatments, or who cannot receive topical treatments.

The drug is currently under clinical development and safety and efficacy has not been fully evaluated. Once the data is analyzed by the FDA, Regeneron and Sanofi plan to commercialize the drug, Regeneron concluded.