FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris
South San Francisco, CA -- June 7, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1
Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. The FDA previously granted Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. With today’s FDA decision, Rituxan is now approved to treat four autoimmune diseases.
“Today’s decision by the FDA provides the first approved treatment option in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”
The FDA approval is based on data from the Ritux 3 trial, a Roche-supported, randomized, controlled trial conducted in France that used Roche-manufactured, European Union (EU)-approved rituximab product as the clinical trial material. The study compared the Ritux 3 regimen (EU-approved rituximab product plus short-term corticosteroids [CS]) to CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission* at month 24 without the use of steroids for two or more months. Results of the study showed that 90 percent of PV patients treated with the Ritux 3 regimen met the endpoint, compared to 28 percent of PV patients treated with CS alone. These results supported the efficacy of Rituxan in treating patients with moderate to severe PV, while tapering off of CS therapy. These results were published in The Lancet in March 2017.2
Recently an international panel of experts, the International Bullous Disease Consensus Group, provided new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology.3 Based on existing European treatment guidelines, a Delphi survey process was used to help achieve international expert consensus. The consensus includes the recommendation to use an anti-CD20 monoclonal antibody (Rituxan) and corticosteroids as first line therapy options for moderate to severe pemphigus.
About Pemphigus Vulgaris
Pemphigus vulgaris is an autoimmune blistering disease affecting the skin and mucous membranes.1 This rare, potentially life-threatening condition accounts for up to 80% of cases of pemphigus, a group of autoimmune disorders which affect 30,000 to 40,000 people in the United States.4
*Complete remission defined as complete epithelialization and absence of new and/or established lesions.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
References
2. Joly P, et al. First-Line Rituximab Combined with Short-Term Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-Label Randomised Trial. The Lancet. March 22, 2017
3. Murrell DF, et al. Diagnosis and Management of Pemphigus: recommendations by an International Panel of Experts, Journal of the American Academy of Dermatology, 2018 https://doi.org/10.1016/j.jaad.2018.02.021 [Article in Press]
4. International Pemphigus & Pemphigoid Foundation. Pemphigus. Available at: http://www.pemphigus.org/research/clinically-speaking/pemphigus/. [Last accessed: May 15, 2018]
Source: Genentech
Posted: June 2018
Related articles
- FDA Approves Rituxan (rituximab) for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) in Children - September 27, 2019
- FDA Approves Rituxan to Treat Two Rare Disorders - April 20, 2011
- FDA Approves Rituxan for First-Line Maintenance Use in Follicular Lymphoma - January 31, 2011
- FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia - February 19, 2010
- FDA Approves Rituxan - The First Targeted B-Cell Therapy for Treatment of Moderate-to-Severe Rheumatoid Arthritis - February 28, 2006
- FDA Approves Rituxan Plus CHOP or other Anthracycline-Based Chemotherapy Regimens for First-Line Treatment of Diffuse Large B-Cell Non-Hodgkin's Lymphoma - February 10, 2006
- Rituxan (rituximab) - First New Drug for Non-Hodgkin's Lymphoma in a Decade Receives FDA Clearance for Marketing - November 26, 1997
Rituxan (rituximab) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.