The Food and Drug Administration (FDA) has granted Priority Review to Rituxan (rituximab; Genentech) for the treatment of pemphigus vulgaris (PV).

PV is a rare, autoimmune, intraepidermal, blistering disease that affects the skin and mucous membranes; the disease can be life-threatening. Currently, there are limited treatment options for PV.

Phase 3 study results released last March demonstrated Rituxan substantially improved pemphigus vulgaris remission rates and led to successful tapering and/or cessation of oral corticosteroid (CS) therapy.  

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In addition, Genentech is currently conducting another Phase 3 trial comparing Cellcept to Rituxan plus a tapering regimen of CS in patients with PV.

“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,” said Sandra Horning, MD, CMO at Genentech. 

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