Dupilumab Designated Breakthrough Therapy for Atopic Dermatitis
Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
The Breakthrough Therapy designation was based on positive results from Phase 1 and Phase 2 clinical trials. Currently a Phase 3 clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.
Dupilumab is a fully human monoclonal antibody directed against the shared IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-3.