FDA Approves Rituxan for Two Rare Disorders

TheU.S.Food andDrugAdministration has approved Rituxan (rituximab) in combination with glucocorticoids (steroids) to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis). Rituxan is an antibody that works by greatly reducing the number of specific immune cells in the blood, known as B cells.

In a single controlled trial, 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared with 53 percent of patients treated with cyclophosphamide. Retreatment with Rituxan was not formally evaluated. Therefore, more data are needed to determine the safety of more than one course of Rituxan, as well as its long-term safety.