FDA Approves Genentech’s Rituxan (rituximab) For Pemphigus Vulgaris

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan^® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

As quoted in the press release:

Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. The FDA previously granted Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. With today’s FDA decision, Rituxan is now approved to treat four autoimmune diseases.

“Today’s decision by the FDA provides the first approved treatment option in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”

Click here to read the full press release.