The US Food and Drug Administration’s (FDA) arthritis advisory committee has voted 13-2 to recommend the approval of Benlysta (belimumab) as a treatment of active systemic lupus.
Benlysta, which is being developed by GlaxoSmithKline and Human Genome Sciences, is the first in a new class of drugs to fight the autoimmune disease.
Under an agreement singed in 2006, Human Genome Sciences is responsibile for conducting the Phase III trials, with assistance from GlaxoSmithKline.
In the Phase III and IV trials, the companies will share the cost of development, sales and marketing. Profits of the product will be split equally.
Systemic lupus erythematosus attacks the body’s cells and tissue, resulting in inflammation and tissue damage. It is a type III hypersensitivity reaction caused by antibody-immune complex formation.