Rituxan Gets Breakthrough Therapy Status for Rare Autoimmune Skin Disorder
Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris, a rare and life-threatening autoimmune disorder causing progressive painful blistering of the skin and mucous membranes.
The designation was supported by data from a randomized trial (Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus) evaluating Rituxan plus oral corticosteroid (CS) vs. CS alone in patients with moderate to severe pemphigus. Data showed that treatment with Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS. Results from this study was published in The Lancet.
The company initiated a randomized, multicenter, double-blind, double-dummy, active-comparator, parallel-arm Phase 3 study (PEMPHIX) to evaluate the efficacy and safety of Rituxan vs. mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus who require 60–120mg daily of oral prednisone or equivalent. Enrollment for this trial is currently ongoing.
Rituxan is currently indicated for the treatment of rheumatoid arthritis, B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Wegener's granulomatosis and microscopic polyangiitis.
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