GSK plc (GSK,GSK.L) said that the US Food and Drug Administration has granted Orphan Drug Designation to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis.
The US FDA's Orphan Drug Designation 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.
Systemic sclerosis 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.
GSK plans to initiate a phase II/III trial of belimumab for systemic sclerosis associated interstitial lung disease in the first half of 2023.
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