Basel, 14 February 2018
FDA grants priority review for Roche’s MabThera/ Rituxan (rituximab) for pemphigus vulgaris
- Pemphigus vulgaris (PV) is a life-threatening, autoimmune condition with limited treatment options1
- The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation for MabThera/Rituxan in PV
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of MabThera/Rituxan® (Rituximab) for the treatment of pemphigus vulgaris (PV), a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1
The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to MabThera/Rituxan for the treatment of PV. Presently, there are limited approved treatment options available for patients with PV.1
“We are committed to developing medicines for rare diseases with limited treatment options, such as pemphigus vulgaris,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “We look forward to continued work with the FDA to hopefully provide patients with a new treatment for this serious and potentially life-threatening disease.”
The sBLA submission is based on data from a Roche-supported randomised trial conducted in France, which evaluated MabThera/Rituxan plus a tapering regimen of low dose oral corticosteroid (CS) treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.2 Results of the study show that MabThera/Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.2
These results were published in The Lancet in March 2017. Genentech is currently conducting another Phase III study in PV which is evaluating MabThera/Rituxan plus a tapering regimen of CS compared to Cellcept (PEMPHIX, NCT02383589).3
About pemphigus vulgaris
Pemphigus vulgaris is an autoimmune, intraepidermal, blistering disease affecting the skin and mucous membranes.1 This rare, life-threatening condition is the most common type of a group of autoimmune disorders collectively called pemphigus.4 It is estimated that around three in every 100,000 people are diagnosed with this disease.1
About the PEMPHIX study
Phase III, randomised, double-blind, double-dummy, active-comparator, parallel-arm multicentre study (PEMPHIX, NCT02383589) was designed to evaluate the efficacy and safety of MabThera/Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent).3
MabThera/Rituxan is approved to treat rheumatoid arthritis (RA) in combination with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumour necrosis factor (TNF) antagonist has been used and did not work well enough.
MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA).
People with serious infections should not receive MabThera/Rituxan. It is not known if MabThera/Rituxan is safe or effective in children.
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.