Lupus Research Alliance Welcomes U.S. FDA Breakthrough Therapy Designation for Enpatoran for the Treatment of Lupus with Skin Manifestations
The Lupus Research Alliance welcomes the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation to enpatoran in clinical development by EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, for the treatment of lupus with active cutaneous manifestations. The FDA grants this designation to expedite the review of drugs for serious conditions that may demonstrate substantial improvement over available … Lupus Research Alliance Welcomes U.S. FDA Breakthrough Therapy Designation for Enpatoran for the Treatment of Lupus with Skin Manifestations
