Rituxan Approved to Treat Severe Pemphigus Vulgaris

The U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan (rituximab) to treat moderate-to-severe phemphigus vulgaris (PV), the first biologic therapy approved and the first major advancement in the treatment of the condition in more than 60 years. PV is a rare and serious potentially life-threatening autoimmune condition characterized by progressive painful blistering of the skin and mucous membranes.

FDA approval was based on the Ritux 3 trial conducted in France that compared Roche’s European Union (EU)-approved rituximab product plus short-term corticosteroids (CS) to CS alone as a first-line treatment in patients with newly diagnosed, moderate-to-severe PV. Results showed 90 percent of PV patients treated with the Ritux 3 regimen met the primary endpoint of complete remission at month 24 without the use of CS for two or more months, compared to 28 percent of PV patients treated with CS alone.

With this FDA approval, Rituxan is now approved to treat four autoimmune diseases: PV, rheumatoid arthritis, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.