GSK (NYSE:GSK) announced that FDA has granted Orphan Drug Designation (ODD) to Benlysta (belimumab) for systemic sclerosis (SSc), a rare autoimmune disease that can affect multiple organs.
Interstitial lung disease (ILD) is the leading cause of death in SSc patients.
The monoclonal antibody Benlysta is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. A soluble ligand belonging to the TNF cytokine family, BLyS is elevated in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. Blocking BLyS decreases the number of abnormal B cells, supporting a reduction in the severity of autoimmune diseases.
GSK shares held steady after announcing the news and Q4 results, dipping 0.20% to $35.19 in mid-day trading.
The company intends to launch a Phase 2/3 study of belimumab for SSc-associated ILD in the first half of 2023.
Benlysta could address an unmet need in systemic sclerosis…