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.