FDA Approves First Biologic for PV


The FDA approved rituximab (Rituxan) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). This is the first biologic therapy approved by the FDA for PV, which was previously granted Breakthrough Therapy Designation and Orphan Drug Designation for PV.

Approval was based on data from the Ritux 3 trial, which included patients with newly diagnosed moderate to severe PV who were randomized to rituximab or corticosteroids. Results of the study showed that 90% of participants who received rituximab achieved complete remission after 24 months compared with 28% of participants who received corticosteroids.  

Common adverse events included infusion site reactions, infections, body aches, fatigue, and nausea, as well as more frequent upper respiratory infections. Other potential adverse events associated with treatment included severe skin and mouth reactions, hepatitis B reactivation, progressive multifocal leukoencephalopathy, tumor lysis syndrome, heart problems, kidney problems, stomach and serious bowel problems, and low blood cell counts.

Pemphigus Vulgaris Therapy Granted Priority Review
Maintenance with Rituximab Monotherapy Prevents Relapse in Severe Pemphigus
Rituximab is also approved for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

“I’m excited by the approval of Rituxan as an effective, much-needed, FDA-approved treatment option for patients who are currently faced with a treatment regimen that can cause significant, long-term side effects,” said Victoria P. Werth, MD, professor of dermatology and medicine at the University of Pennsylvania.