Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

Decision Could Speed Up Treatment Approval for Skin-Related Lupus Manifestation

NEW YORK, Jan. 28, 2026 /PRNewswire/ -- The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation for litifilimab (BIIB059) in clinical development by Biogen Inc. for the treatment of cutaneous lupus erythematosus (CLE) – a chronic skin disease for which there are no specifically approved treatments. The FDA grants this designation to expedite the review of drugs that may demonstrate substantial improvement over available therapies.

A common manifestation of lupus – a chronic and complex autoimmune disease – CLE primarily causes inflammation of the skin. Symptoms vary, but can include butterfly rashes, ring-shaped sores, or red, scaly patches on the skin. CLE can cause irreversible scarring, skin pigment changes, and hair loss – significantly impacting quality of life.

"CLE symptoms affect 70-85% of people with lupus and can be debilitating," Albert T. Roy, President & CEO of the Lupus Research Alliance, said. "This designation for litifilimab is critical to accelerate progress for a condition for which there is no specifically approved treatment. Pioneering work funded by the Lupus Research Alliance over two decades ago discovered that type 1 interferons – like those targeted by litifilimab – play a major role in inflammation and drive the development of lupus, setting the stage for the progress seen by treatments in development such as this from Biogen. "

Litifilimab is a humanized IgG1 monoclonal antibody (mAb) targeting BDCA2. As reported in a press release issued by Biogen, the Breakthrough Therapy designation was granted based on data from the Phase 2 LILAC study. Litifilimab is in Phase 3 study with the ongoing AMETHYST trial.

The Lupus Research Alliance has served as a longstanding partner to Biogen. Clinical affiliate Lupus Therapeutics has collaborated with Biogen on Phase 2 and 3 clinical trials investigating litifilimab, ensuring the perspectives of people living with lupus are incorporated throughout the drug development process. Additionally, several of the studies are led by members of the Lupus Clinical Investigators Network (LuCIN), overseen by Lupus Therapeutics.

Biogen is also a member of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), convened by the Lupus Research Alliance as a public-private partnership with the FDA that focuses specifically on advancing the development of safer and more effective treatments urgently needed for people with lupus. The consortium includes a working group focused on CLE to pave the way for therapies that can benefit people with this condition.

Additional information about the designation is available via Biogen's media release.

About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15–45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus.

About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering scientific talent, and driving discovery toward better diagnostics, improved treatments and, ultimately, a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

For more information or to donate to lupus research, visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram.

SOURCE Lupus Research Alliance