(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food allergies. If approved, Xolair would be the first medicine capable of reducing allergic reactions to multiple foods following accidental exposure. The FDA is expected to make a decision on approval in the first quarter of 2024. The application is based on positive interim analysis results from the phase III OUtMATCH study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the Consortium of Food Allergy Research (CoFAR). The study showed that Xolair significantly increased the amount of peanut and other allergens it took to cause an allergic reaction in children and adolescents with food allergies. Food allergies affect millions of children and adults in the U.S., and the prevalence has been rising. Xolair is already FDA-approved for other indications, and more than 700,000 patients have been treated with it in the U.S.
(PRESS RELEASE) BASEL , 20-Dec-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy. If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”). The filing acceptance is based on positive interim analysis results from stage 1 of the National Institutes of Health (NIH)-sponsored pivotal phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods. If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure. The FDA is expected to make a decision on approval in the first quarter of 2024.4
“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study. The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.”
At a pre-planned interim analysis, an independent Data and Safety Monitoring Board (DSMB) examined the data on the first 165 children and adolescents aged 1 to 17 years who participated in the first stage of the trial and determined the study met its primary endpoint and key secondary endpoints. These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) it took to cause an allergic reaction in children and adolescents with food allergies. Safety findings were consistent with the known benefit-risk profile of Xolair across its approved indications and in previous clinical trials.5
The phase III OUtMATCH study is being sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) across 10 clinical sites throughout the U.S. The study is also supported by Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. Detailed results from the OUtMATCH study have been submitted by NIAID and CoFAR to a peer-reviewed journal.
Food allergies affect up to 17 million children and adults in the U.S. and food allergy prevalence has been on the rise for the past 20 years.1,2,3 Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis.6 More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.1,3,6
In August 2018, the FDA granted Breakthrough Therapy Designation for Xolair for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.7 The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat serious conditions. Xolair is currently FDA-approved for the treatment of moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).5 Since its initial approval in 2003, more than 700,000 patients have been treated with Xolair in the U.S.8
In the U.S., Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.
About the OUtMATCH Study4
The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is an NIH-sponsored, three-stage, multicentre, randomised, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods. The study includes three stages, of which only stage 1 has been completed.
Stage 1 patients were randomised to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. The Xolair dose and dosing interval were determined by total serum immunoglobulin E (IgE) level and body weight.
About Xolair
Xolair is the only approved antibody designed to target and block IgE. By reducing free immunoglobulin E (IgE), down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimises the release of mediators throughout the allergic inflammatory cascade.
About Roche in Immunology
The Roche Group’s immunology medicines include: Actemra®/RoActemra® (tocilizumab) for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant cell arteritis (GCA) and for the treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS); Rituxan®/MabThera® (rituximab) for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis and for pemphigus vulgaris (PV); Xolair® (omalizumab) for allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme® (dornase alfa) for cystic fibrosis; and Esbriet® (pirfenidone) for idiopathic pulmonary fibrosis (IPF). Roche has more than 15 investigational medicines in clinical development for immunological diseases that include asthma, autoimmune diseases, rheumatoid arthritis, ulcerative colitis and Crohn’s disease.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
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.
All trademarks used or mentioned in this release are protected by law.
References
[1] Gupta RS, Warren CM, Smith BM, et al. Prevalence and Severity of Food Allergies Among US Adults. JAMA Netw Open. 2019;2(1):e185630. doi:10.1001/jamanetworkopen.2018.5630.
[2] Warren CM, Jiang J, Gupta RS. Epidemiology and Burden of Food Allergy. Curr Allergy Asthma Rep. 2020 Feb 14;20(2):6. doi: 10.1007/s11882-020-0898-7. PMID: 32067114; PMCID: PMC7883751.
[3] Gupta RS, Warren CM, Smith BM et al. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. 2018 Dec;142(6):e20181235. doi: 10.1542/peds.2018-1235.
[4] Clinical Trials.gov. Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (OUtMATCH) [Internet; cited November 2023]. Available from: https://clinicaltrials.gov/study/NCT03881696.
[5] Xolair (omalizumab) Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals Corporation 2024.
[6] USDA Food Safety and Inspection Service. Food Allergies. https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-allergieshttps://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-allergies. Accessed November 2023.
[7] Roche. FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies. August 12, 2018. https://www.roche.com/investors/updates/inv-update-2018-08-13b.
[8] Data on file. Genentech, Inc.
Media Contacts:
Media Relations:
Phone: +41 61 688 8888
e-mail: media.relations@roche.com
SOURCE: ROCHE
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- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP