Merck KGaA's Lupus Drug Gets US FDA Breakthrough Therapy Designation

The US Food and Drug Administration granted breakthrough therapy designation to Merck KGaA's (MRK.F) enpatoran for the treatment of lupus with active cutaneous manifestations. The designation for the German science and technology company's oral selective toll-like receptor 7/8 inhibitor is supported by results from the phase 2 Willow study, according to a Wednesday release. In the study, patients who were treated with enpatoran showed clinically meaningful improvements in lupus symptoms, specifically in people with the skin manifestations.