The FDA granted Breakthrough Therapy Designation to Merck KGaA’s enpatoran for lupus patients with active skin manifestations. This designation accelerates the development and review of drugs showing potential for substantial improvement over existing treatments.
Enpatoran functions as a selective inhibitor of toll-like receptors (TLR) 7 and 8. The FDA based its decision on positive results from the Phase 2 WILLOW study. This trial demonstrated clinically meaningful improvements in symptoms, specifically for patients with active cutaneous manifestations.
No approved therapies currently exist specifically for the skin manifestations of lupus. These symptoms affect up to 85% of the lupus patient population.
Merck KGaA has initiated a global Phase 3 program, called ELOWEN, to further evaluate the efficacy and safety of the drug. If approved, enpatoran would become the first targeted therapy for this patient group.