Breaking News
June 20, 2018 - New approach could provide objective and easy-to-obtain measure of dietary adherence
June 20, 2018 - ‘Miracle treatment’ long-term success for babies with diabetes
June 20, 2018 - Rheumatoid Arthritis patients with depression have increased risk of disease flare
June 20, 2018 - NTU launches new research centers to prevent and treat diseases affecting Singaporeans
June 20, 2018 - Researchers examine risk factors for opioid dependence in patients undergoing surgery for DS
June 20, 2018 - Study finds substantial variation in cardiovascular risk across India
June 20, 2018 - Kidney donation among carefully-selected older adults poses minimal risks
June 20, 2018 - Effects of atrial fibrillation can be reduced or reversed by losing weight
June 20, 2018 - Allergan’s Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial
June 20, 2018 - The novel insights of proteoglycans in mineralized tissues
June 20, 2018 - Scientists shed light on key aspect of healthy cell division
June 20, 2018 - Circulating bone turnover markers not linked to hip fracture risk, shows study
June 20, 2018 - Scientists obtain key information about proteins from single human cells
June 20, 2018 - Scientists identify novel genes linked with infantile forms of schizophrenia
June 20, 2018 - Low-dose aspirin could help pregnant women with high blood pressure avoid a dangerous condition
June 20, 2018 - Unusual gene provides novel insight into how the brain wires itself
June 20, 2018 - Study finds IV acetaminophen to be no more effective than oral counterpart for colectomy patients
June 20, 2018 - MAARA to celebrate its 50th anniversary with lecture titled ‘The Future of Asthma’
June 20, 2018 - Administration eases way for small businesses to buy insurance in bulk
June 20, 2018 - High-Quality Diet May Decrease Mortality Risk in Cancer Survivors
June 20, 2018 - JAMA editorial on ECG screening and cardiac risks
June 20, 2018 - Study hints at benefits of lifestyle interventions in reducing dementia risk
June 20, 2018 - Low blood levels of vitamin D linked to increased risk of interstitial lung disease
June 20, 2018 - Simple cognitive task after brain injury improves memory function, study finds
June 20, 2018 - Clinical trial targets metastatic colorectal cancer with new combination therapy
June 20, 2018 - Researchers discover pesticide-free way to limit mosquitoes and reduce spread of West Nile virus
June 20, 2018 - Persistent psychological stress contributes to development and progression of vision loss
June 20, 2018 - Study introduces novel strategy to obtain reasonable drug cost estimates for cost-effectiveness analyses
June 20, 2018 - Does Salt Water Help Your Cut? And Other Health Myths of Summer
June 20, 2018 - Scientists help identify genetic markers for prostate cancer in global DNA download
June 19, 2018 - Common ingredient in toothpaste and hand wash could contribute to antibiotic resistance
June 19, 2018 - WHO launches multiyear campaign to eliminate use of trans fat
June 19, 2018 - Scientists could build better drugs by learning from bacteria-derived molecules
June 19, 2018 - Comparative silence between firing spikes of neurons reveals what they are really up to
June 19, 2018 - JAK inhibitors associated with aggressive lymphoma
June 19, 2018 - SetPoint announces positive long-term results of bioelectronic medicine to treat rheumatoid arthritis
June 19, 2018 - Hypnosis may help reduce fear, anxiety in children undergoing treatment for cancer
June 19, 2018 - Scientists point to potentially promising treatment target for deadly brain cancers
June 19, 2018 - After opioid overdose, only 30 percent get medicine to treat addiction
June 19, 2018 - Patients with mild Alzheimer’s disease over age 65 continue to derive benefit from DBS-f treatment
June 19, 2018 - Microbiotica partners with University of Adelaide to develop defined bacterial product for ulcerative colitis
June 19, 2018 - Paratek Presents New Analysis from Combined Phase 3 Skin Infection Studies Highlighting Efficacy of Omadacycline in Treating Drug Resistant S. aureus
June 19, 2018 - Autism is not linked to eating fish in pregnacy
June 19, 2018 - Scientists create universal assembly method to enhance cancer therapy and diagnostics
June 19, 2018 - Follow-up study confirms success of physiological test for autism
June 19, 2018 - FDA provides guidance on Novus Therapeutics’ development path for OP-02 to treat otitis media
June 19, 2018 - Scientists discover new mechanism controlling multiple sclerosis risk
June 19, 2018 - Award granted to Neem Biotech to develop antimicrobial intervention for chronic lung infections
June 19, 2018 - Study finds combined risk of death and developing cancer to be lowest in light drinkers
June 19, 2018 - Novel app teaches users how to stop life-threatening bleeding and save lives
June 19, 2018 - Single blood sample can provide adequate confirmation of diabetes
June 19, 2018 - New stimulation method increases hope for improving disorders of consciousness
June 19, 2018 - FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion
June 19, 2018 - Defining the biology of autism
June 19, 2018 - Researchers use optogenetics to shape tissues
June 19, 2018 - Scientists discover genetic causes underlying group of related infant cancers
June 19, 2018 - Innovative digital home testing kit benefits patients with kidney conditions
June 19, 2018 - New guidance on selection and evaluation of wearable devices for use in regulatory clinical trials
June 19, 2018 - Researchers understand the role of brain’s ‘reward circuit’ in autism spectrum disorder
June 19, 2018 - Researchers propose new strategy to combat micro-pollutants in water
June 19, 2018 - Illicit Opioid Trade Up With Restrictions on Hydrocodone
June 19, 2018 - New 3-D imaging analysis technique could lead to improved arthritis treatment
June 19, 2018 - Study finds increased risk of mortality in people with cold agglutinin disease in five years after diagnosis
June 19, 2018 - Psychologists can play important role in treating alcohol problems
June 19, 2018 - Study finds elevated risk of congenital defects in lithium-exposed infants
June 19, 2018 - Test-Taking Can Be Tough for Kids With Vision Problems
June 19, 2018 - Injections for knee osteoarthritis—’subtle but significant’ impact of revisions in clinical practice guidelines
June 19, 2018 - Researchers develop new approach to assess effectiveness of Men B vaccine
June 19, 2018 - Study shows link between financial literacy and hospitalization risk in older adults
June 19, 2018 - If you’ve got hep C, spitting can be a felony
June 19, 2018 - New study examines how the brain plays role in rheumatoid arthritis inflammation
June 19, 2018 - Researchers discover new defense mechanism against oxygen radicals
June 19, 2018 - WVU researcher aims to produce updated whooping cough vaccine
June 19, 2018 - Scientists develop novel computational framework to support personalized cancer treatment
June 19, 2018 - Rate of dementia on the decline—but beware of growing numbers
June 19, 2018 - Microglia play protective role in response to retinal detachment, shows study
June 19, 2018 - Technology breakthrough could enable detection of fetal genetic abnormalities in early pregnancy
June 19, 2018 - Novel chip can be used to identify rhinovirus strains as cause of asthma
June 19, 2018 - Effects of in vitro fertilization depend on genetic variation inherited from parents
June 19, 2018 - Heart attack patients unable to resume work report depression and financial hardship
FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris

FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris

image_pdfDownload PDFimage_print

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

1. Medscape. Pemphigus Vulgaris. Available at: http://emedicine.medscape.com/article/1064187-overview. [Last accessed: May 15, 2018]

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:

Tagged with:

About author

Related Articles