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EMD Serono's enpatoran receives FDA Breakthrough Therapy Designation to further develop treatment for active skin manifestations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to EMD Serono's investigational drug, enpatoran, for the treatment of systemic lupus erythematosus (SLE) in those with active cutaneous skin manifestations. This designation is given only to therapies that show early promise for serious conditions and signals the FDA's commitment to speeding up their development and review. This announcement marks a significant milestone for the lupus community, as there are currently no approved targeted therapies specifically for lupus skin manifestations.
Enpatoran is an investigational oral therapy that selectively inhibits toll-like receptors 7 and 8 (TLR7/8), proteins involved in immune pathways that drive lupus-related inflammation. In EMD Serono's Phase 2 WILLOW study, which included participants with both cutaneous lupus erythematosus and SLE, participants treated with enpatoran experienced clinically meaningful improvements in lupus symptoms, particularly those with active skin manifestations. These results formed the basis for the FDA's Breakthrough Therapy Designation, recognizing the potential of the therapy to provide benefits beyond current treatment options.
Further research is currently underway in the global Phase 3 ELOWEN-1 and ELOWEN-2 studies, which are evaluating enpatoran in people with lupus and active skin manifestations. Learn more about lupus and the skin.
