FDA grants breakthrough therapy designation to enpatoran for cutaneous lupus

The FDA has granted breakthrough therapy designation to enpatoran for lupus with active skin manifestations, according to a press release from EMD Serono.The designation comes in the wake of the phase 2, placebo-controlled WILLOW study, in which enpatoran (EMD Serono), an oral selective toll-like receptor (TLR) 7/8 inhibitor, demonstrated significant and dose-dependent impacts on disease activity