FDA grants priority review to Xolair (omalizumab) for children and
adults with food allergies based on positive National Institutes of
Health phase III study results
- If approved, Xolair would
be the first medicine to reduce allergic reactions to multiple
foods following an accidental exposure
- Interim analysis results
from first-of-its-kind phase III OUtMATCH study showed Xolair
significantly increased the amount of peanut, milk, egg and cashew
it took to cause an allergic reaction
- 17 million people in the
U.S. have confirmed food allergies and more than 40% of children
and more than half of adults with food allergies have experienced a
severe reaction at least once1,2,3
Basel, 19 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today 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 Study4The
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-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.
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