Pemphigus Vulgaris Treatment Granted Priority Review
Phase 3 study results demonstrated the treatment substantially improved pemphigus vulgaris remission rates.
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.
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.
FDA grants priority review for Genentech's Rituxan® (rituximab) for pemphigus vulgaris [press release]. South San Francisco, CA: Genentech; February 13, 2018. Accessed February 23, 2018.