FDANews
FDAnews Drug Daily Bulletin

FDA Grants Breakthrough Therapy Designation for Rituxan in Pemphigus Vulgaris

March 30, 2017

Genentech received a breakthrough therapy designation for Rituxan (rituximab) for pemphigus vulgaris, characterized by progressive painful blistering of the skin and mucous membranes.

The FDA granted orphan drug designation to Rituxan for the treatment of pemphigus vulgaris in 2015.

The designation was granted based on data from a randomized trial conducted in France that evaluated Rituxan plus an oral corticosteroid treatment, compared to the steroid treatment alone in first-line patients with moderate to severe pemphigus.

This is the 15th breakthrough therapy designation granted to Genentech since 2013.

View today's stories