Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus [Yahoo! Finance]
Biogen Inc. (BIIB)
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Source: Yahoo! Finance
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 whi
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- Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment OptionsGlobeNewswire
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