With the approval, rituximab has become the first biologic therapy approved by the FDA for PV, and the first major advancement in treatment of the condition in 6 decades.
Officials with the FDA have approved rituximab (Rituximab) for the treatment of adults with a rare, life-threatening autoimmune disease.
The therapy has been approved to treat pemphigus vulgaris (PV), a condition characterized by progressive blistering of the skin and mucous membranes. With the approval, rituximab has become the first biologic therapy approved by the FDA for PV, and the first major advancement in treatment of the condition in 6 decades, according to Genentech.
Along with PV, rituximab is approved for the treatment of autoimmune diseases rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyganiitis. It was previously granted Priority Review, Breakthrough Therapy Designation, and Orphan Drug Designation by the FDA for its indication for adults with PV.
Its approval was based on data from the Ritux 3 trial, a randomized, controlled study conducted in France that tested the European Union (EU)-approved rituximab product in adult patients. Researchers compared rituximab plus short-term corticosteroids (CS) to CS monotherapy as a first-line treatment for patients recently diagnosed with moderate to severe PV.
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