The Lupus Research Alliance has welcomed the decision by the US Food and Drug Administration (FDA) to grant Breakthrough Therapy designation to litifilimab, an investigational treatment being developed by Biogen for Cutaneous Lupus Erythematosus (CLE). The designation is intended to accelerate the development and regulatory review of therapies that demonstrate the potential for substantial improvement over existing treatment options.

CLE is a common and often debilitating manifestation of lupus, a chronic autoimmune disease, affecting an estimated 70–85 percent of people living with lupus. The condition primarily causes inflammation of the skin and can present as butterfly rashes, ring-shaped lesions, or red scaly patches. In severe cases, CLE can lead to permanent scarring, pigmentation changes and hair loss, significantly affecting patients’ quality of life. Currently, there are no therapies specifically approved for the treatment of CLE.

Albert T. Roy, President and CEO of the Lupus Research Alliance, said the designation marks an important step forward for patients. He noted that the organisation’s early research investments helped establish the role of type I interferons in driving lupus-related inflammation, an insight that laid the foundation for therapies such as litifilimab, which targets this pathway.

Litifilimab is a humanised IgG1 monoclonal antibody designed to target BDCA2, a receptor involved in interferon signalling. According to Biogen, the FDA’s decision was based on results from the Phase II LILAC study. The therapy is currently being evaluated in a Phase III clinical trial, the ongoing AMETHYST study.

The Lupus Research Alliance has been a long-standing partner in the development of litifilimab. Its clinical affiliate, Lupus Therapeutics, has collaborated with Biogen across Phase II and Phase III trials to ensure that patient perspectives are embedded throughout the drug development process. Several of the studies are being led by investigators from the Lupus Clinical Investigators Network (LuCIN), overseen by Lupus Therapeutics.

Biogen is also a participant in the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), a public–private partnership convened by the Lupus Research Alliance in collaboration with the FDA. The consortium focuses on advancing safer and more effective treatments for lupus, with a dedicated working group addressing the unmet needs in cutaneous lupus erythematosus.