Rituximab Gains FDA Approval for Pemphigus Vulgaris

The US Food and Drug Administration (FDA) has 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.

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