GSK reports Benlysta granted orphan drug designation by FDA

GSK plc announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Benlysta, a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. GSK plans to initiate a phase II/III trial of belimumab for systemic sclerosis associated interstitial lung disease, or SSc-ILD, in the first half of 2023.