FDA fast-tracks Genentech’s Rituxan

SOUTH SAN FRANCISCO, Calif. — The U.S. Food and Drug Administration granted Breakthrough Therapy Designation status to Genentech’s Rituxan, intended for the treatment of pemphigus vulgaris, a painful, disfiguring and potentially fatal autoimmune disease characterized by progressive blistering of skin and/or mucous membranes.

“I’m excited by the potential for Rituxan to serve as a 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, M.D., professor of Dermatology and Medicine at the University of Pennsylvania.

This is the 15th Breakthrough Therapy Designation granted to Genentech since 2013. The FDA’s Breakthrough Therapy Designation, designed to expedite the development and review of medicines for serious diseases and help ensure patients have access to them as soon as possible, was granted based on data from a Phase II study. This study evaluated Rituxan plus oral corticosteroid treatment compared to corticosteroid as a first-line treatment in patients with moderate to severe PV.

Pemphigus vulgaris is an autoimmune, intraepidermal, blistering disease affecting the skin and mucous membranes. It is the most common type of a group of autoimmune disorders collectively called pemphigus. It is estimated that around three in every 100,000 people are diagnosed with this disease.