Health
Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus
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.
About this update from Biogen Inc.
[{"type":"text","content":"Decision Could Speed Up Treatment Approval for Skin-Related Lupus Manifestation ","length":79,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":517,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Lupus Research Alliance)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Lupus Research Alliance)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":155,"url":"https://media.zenfs.com/en/prnewswire.com/2722fb61c774163e4f8790016aaa1e69"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/uQbodKLolbqPKXXGxdKrDA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI3MztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/2722fb61c774163e4f8790016aaa1e69","width":400,"height":155}},"href":"https://mma.prnewswire.com/media/1035705/Lupus_Research_Alliance_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":357,"tagName":"p"},{"type":"text","content":""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 treat...