Posted by Michael Wonder on 24 Mar 2017
FDA grants breakthrough therapy designation for Rituxan (rituximab) in pemphigus vulgaris
23 March 2017 - Fifteenth breakthrough therapy designation granted to Genentech medicines since 2013.
Genentech today announced that the U.S. FDA has granted Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes.
FDA breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. Genentech is currently enrolling a Phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options.
