The Food and Drug Administration (FDA) has approved Rituxan (rituximab; Genentech and Biogen) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), an autoimmune blistering disease that affects the skin and mucous membranes.
The approval was based on data from the Ritux 3 trial (N=90) which compared rituximab + short-term oral prednisone (Ritux 3 regimen) to oral prednisone alone as a first-line treatment for patients with newly diagnosed moderate to severe PV. Results showed that 90% of PV patients treated with the Ritux 3 regimen had complete remission off-therapy (without the use of steroids for ≥2 months) at month 24 (primary endpoint) compared with 28% of those treated with prednisone alone.
“Today’s decision by the FDA provides the first approved treatment option in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”
Rituxan, a CD20-directed cytolytic antibody, is also approved for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis.
It is supplied in 100mg/10mL and 500mg/50mL single-use vials.
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