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Benlysta granted Orphan Drug Designation by US FDA
Benlysta granted Orphan Drug Designation by US FDA.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 1 February 2023, London UK\n \n \n \n \n \n \n \n \n Benlysta\n \n \n granted Orphan Drug Designation by US FDA for the potential treatment of systemic sclerosis\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), 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 (SSc-ILD) in the first half of 2023.\n \n \n \n \n \n Systemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues and can affect the musculoskeletal system, heart, lungs, kidneys, skin, and other organs. Interstitial lung disease (ILD) is the leading cause of death in SSc, affecting as many as half of people living with the disease.1,2\n \n \n \n \n \n With limited treatment options available for SSc-ILD, this Orphan Drug Designation reflects the need for further research and the potential for belimumab to address a critical need for people living with this debilitating condition. GSK continues to follow the science to explore how belimumab may be able to address an unmet need in B-cell-driven autoimmune diseases.\n \n \n \n \n \n The US FDA's\n ODD is a special status granted to support the development and evaluation of potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.\n \n \n \n \n \n \n \n \n About Benlysta (belimumab)\n \n \n \n \n \n Benlysta\n \n (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS, which is found to be increased in patients with systemic autoimmune diseases like systemic lupus erythematosus (SLE) and lupus nephritis (LN)\n .\n 3\n A fully human monoclonal antibody, Benlystainhibits the prolonged survival of B cells induced by increased BLyS, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. The US FDA first approved Benlysta for the treatment of activeSLE; it is the first and only approved biologic for both SLE and LN in more th...