24 March 2017 - - The US Food and Drug Administration has granted Breakthrough Therapy Designation status to US-based biotechnology company Genentech's Rituxan (rituximab) for pemphigus vulgaris, the company said.

Pemphigus vulgaris is a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

Genentech a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).

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.

This is the fifteenth Breakthrough Therapy Designation granted to Genentech medicines since 2013.

Breakthrough Therapy Designation status was granted based on data from a Roche-supported randomized trial conducted in France (Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus), which evaluated Rituxan plus oral corticosteroid treatment compared to CS as a first-line treatment in patients with moderate to severe pemphigus.

Results of the study, published in The Lancet, show that Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.

In 2015, the FDA granted Orphan Drug Designation to Rituxan for the treatment of pemphigus vulgaris.

Genentech initiated a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm multicenter study (PEMPHIX, NCT02383589) to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent).