Rituxan first biologic approved for pemphigus vulgaris in USA

The US Food and Drug Administration has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening skin condition characterized by progressive painful blistering of the skin and mucous membranes.

Marketing by Roche (ROG: SIX) subsidiary Genentech, Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years.

The FDA previously granted Priority Review, Breakthrough Therapy designation and Orphan Drug designation to Rituxan for the treatment of PV. With Thursday’s FDA decision, Rituxan is now approved to treat four autoimmune diseases.