Litifilimab receives FDA breakthrough therapy designation for Cutaneous Lupus Erythematosus

Biogen has recently announced that the U.S. FDA has granted Breakthrough Therapy Designation for litifilimab for the treatment of cutaneous lupus erythematosus. Litifilimab is a first in-class, humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2.

“The breakthrough therapy designation for litifilimab illustrates the FDA’s recognition of cutaneous lupus as a serious disease that urgently requires new therapies,” said Victoria Werth, MD, MS, a professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania, and one of the researchers who is conducting the phase 3 trial. “With topical steroids and antimalarials as the initial therapies for managing CLE and no alternatives specifically approved for CLE, there is a need for effective, targeted treatments, and that could be a drug like litifilimab.”

Note that the designation is intended to expedite the development and review of drugs for serious conditions, and is based on the totality of litifilimab data, including the results from the Phase 2 LILAC study. The LILAC data were previously published in The New England Journal of Medicine and demonstrated that litifilimab reduced skin disease activity in people with CLE compared to placebo.

“The FDA grants breakthrough therapy designation to programs based on the seriousness of the condition and the potential of the therapeutic candidate to provide substantial improvements over available therapies. The FDA’s designation reinforces Biogen’s belief that litifilimab could be a first-in-class therapy targeting BDCA2 for cutaneous lupus erythematosus,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “This designation is a significant milestone for litifilimab as we advance the ongoing AMETHYST Phase 3 study, with the goal of bringing a new potential therapeutic option to the millions of people living with CLE.”

“The Lupus Research Alliance is dedicated to advancing lupus research, and today’s FDA Breakthrough Therapy designation for litifilimab reinforces our shared understanding of cutaneous lupus as a serious, debilitating condition that urgently needs therapies that can alter the course of the disease,” said Albert T. Roy, President & CEO of the Lupus Research Alliance. “Incorporating the voices of people living with cutaneous lupus is vital to advancing drug development, and through our clinical affiliate, Lupus Therapeutics, we are proud to collaborate with Biogen on the cutaneous lupus erythematosus clinical trials for litifilimab. As a convenor bringing together leading industry partners, clinicians, patients, and FDA experts, the Lupus Research Alliance is encouraged by this progress to accelerate a potential new treatment that may improve the quality of life for those affected by CLE.”

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biogen, Biogen’s Litifilimab, Cutaneous Lupus Erythematosus, litifilimab, lupus