FDA accepts filing of Rituxan for pemphigus vulgaris and grants Priority Review.- Genentech/Roche.

Genentech/Roche announced that the FDA has accepted the company�s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan (rituximab) for the treatment of pemphigus vulgaris (PV), a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. Presently, there are limited approved treatment options available for patients with PV.

The sBLA submission is based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid (CS) treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. Results of the study show that Rituxan provides substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy. These results were published in The Lancet in March 2017. Genentech is currently conducting another Phase III study in PV which is evaluating Rituxan plus a tapering regimen of CS compared to Cellcept (PEMPHIX, NCT02383589).