FDA Breakthrough Therapy designation for Rituxan in pemphigus vulgaris

The US Food and Drug Administration has granted Breakthrough Therapy designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes, from Genentech, a subsidiary of Swiss drug giant Roche (ROG: SIX).

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.

MabThera/Rituxan (rituximab), for common forms of blood cancer, rheumatoid arthritis and certain types of vasculitis, is already Roche’s top selling drug, generating revenues of 7.30 billion Swiss francs ($7.36 billion) in 2016.