FDA actions

FDA actions

The FDA has approved rituximab (Rituxan) for the expanded indication to treat Wegener's granulomatosis and microscopic polyangiitis, two rare vasculitides. The effectiveness of rituximab was demonstrated in a single control trial in which 197 patients with either condition were randomized to rituximab plus glucocorticoids or oral cyclophosphamide plus glucocorticoids. After 6 months, 64% of the patients treated with rituximab had a complete remission compared to 53% of patients treated with cyclophosphamide. Rituximab is manufactured by Genentech.