Lebrikizumab Granted Fast Track Designation for Treatment of Atopic Dermatitis
The FDA has granted Fast Track Designation for lebrikizumab (Dermira) to treat patients with moderate-to-severe atopic dermatitis (AD).
The FDA has granted Fast Track Designation for lebrikizumab (Dermira) to treat patients with moderate-to-severe atopic dermatitis (AD).
Lebrikizumab is currently being evaluated in 2 different phase 3 trials, ADvocate 1 and ADvocate 2, to confirm the safety and efficacy in adolescent and adult patients with AD.
The monoclonal antibody is designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling. This causes lebrikizumab to inhibit the biological effects of IL-13 in a targeted and efficient fashion.
IL-13 is a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of atopic dermatitis. Its effects promote type 2 inflammation and mediates its effect on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
Reference
Dermira receives fast track designation from FDA for lebrikizumab for the treatment of atopic dermatitis [news release]. Menlo Park, CA; BusinessWire: December 10, 2019. https://www.businesswire.com/news/home/20191210005383/en/Dermira-Receives-Fast-Track-Designation-FDA-Lebrikizumab. Accessed December 10, 2019.
