Rituximab Gains FDA Priority Review for Rare Disease

The US Food and Drug Administration (FDA) has accepted a Supplemental Biologics License Application (sBLA) and granted Priority Review designation to rituximab (Rituxan, Genentech), a treatment for the rare autoimmune condition pemphigus vulgaris (PV).

The drug had been previously given Breakthrough Therapy and Orphan Drug designations, as the treatment options for patients with PV are very limited to only a few immunosuppressant therapies, such as azathloprine, mycophenolate, cyclophosphamide, and cyclosporine.

“We are committed to developing medicines for rare diseases with limited treatment options, such as pemphigus vulgaris,” Sandra Horning, MD, the chief medical officer and head of Global Product Development at Genentech said in a statement. “We look forward to continued work with the FDA to hopefully provide patients with a new treatment for this serious and potentially life-threatening disease.”

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