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SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.
The FDA approved Rituxan (rituximab), in combination with a type of steroid known as glucocorticoids, to treat patients with Wegener’s granulomatosis and microscopic polyangiitis. Both disorders cause inflammation of the blood cells, also known as vasculitis, which can lead to tissue damage. WG mostly affects the respiratory tract, while MPA affects the kidneys, lungs, nerves, skin and joints. Both are considered orphan diseases because they affect fewer than 200,000 people in the United States, but their causes remain unknown.
“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said.