FDA approves Xolair as first and only medicine for children and
adults with one or more food allergies
- Approval is based on data
from the NIH-sponsored Phase III OUtMATCH study, which showed a
significantly higher proportion of food allergy patients as young
as 1 year treated with Xolair could tolerate small amounts of
peanut, milk, egg and cashew without an allergic reaction, compared
to placebo
- More than 40% of children
and more than half of adults with food allergies have experienced a
severe reaction at least
once1,2
- Detailed OUtMATCH results
will be featured in a late-breaking symposium at
the 2024 AAAAI Annual Meeting
Basel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) announced today that the U.S. Food and Drug Administration
(FDA) has approved Xolair® (omalizumab) for the
reduction of allergic reactions, including anaphylaxis, that may
occur with accidental exposure to one or more foods in adult and
paediatric patients aged 1 year and older with IgE-mediated food
allergy. People taking Xolair for food allergies should continue to
avoid all foods they are allergic to (commonly referred to as “food
allergen avoidance”). Xolair should not be used for the emergency
treatment of any allergic reactions, including anaphylaxis.
Immunoglobulin E (IgE)-mediated food allergies are the most common
type and are typically characterised by the rapid onset of symptoms
following exposure to certain food allergens.3 Xolair is
the first and only FDA-approved medicine to reduce allergic
reactions in people with one or more food allergies. Xolair is
widely available and can now be prescribed for appropriate patients
with IgE-mediated food allergy in the U.S.
“Xolair offers patients and families an important new treatment
option that can help redefine the way food allergies are managed
and reduce the often-serious allergic reactions that can result
from exposure to food allergens,” said Levi Garraway, M.D., Ph.D.,
Roche's Chief Medical Officer and Head of Global Product
Development. “Today’s approval builds on 20 years of patient
experience and an established efficacy and safety profile since
Xolair was first approved in allergic asthma. We look forward to
bringing this treatment to the food allergy community who have long
awaited an advancement.”
The FDA approval is based on positive data from the Phase III
OUtMATCH study, which evaluated Xolair in patients aged 1 to 55
years allergic to peanuts and at least two other food allergens,
including milk, egg, wheat, cashew, hazelnut and walnut. The
OUtMATCH study is sponsored and funded by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), and is being conducted by the
NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10
clinical sites across the U.S. led by Johns Hopkins Children's
Center and co-led by Stanford School of Medicine. Detailed results
from the study will be featured in a late-breaking symposium at the
2024 American Academy of Allergy, Asthma & Immunology (AAAAI)
Annual Meeting on Sunday, 25 February.
“As more and more people are affected by food allergies, the
need for a new approach to help prevent serious and often
life-threatening allergic reactions and emergencies is critical,”
said Sung Poblete, R.N., Ph.D., CEO of FARE (Food Allergy Research
and Education). “As someone with food allergies, I know firsthand
the significant impact they can have on people and their loved
ones, and I share in the community’s excitement for this
approval.”
“The stress of living with food allergies can weigh heavily on
people and their families, particularly when navigating events like
children's birthday parties, school lunches, and holiday dinners
with friends and family,” said Kenneth Mendez, president and CEO of
the Asthma and Allergy Foundation of America (AAFA). “Given the
growing prevalence of food allergies, this news offers hope to the
many children and adults who may benefit from a new way to help
manage their food allergies.”
Patients entered the OUtMATCH study unable to tolerate up to 100
mg of peanut protein (equivalent to about one third of a peanut),
and up to 300 mg each of milk, egg and cashew protein. After 16 to
20 weeks of treatment with Xolair or placebo, each participant
completed four food challenges, receiving gradually increasing
amounts of foods they are allergic to (and a placebo ingredient),
in order to assess their ability to consume a single dose of at
least 600 mg of peanut protein (primary endpoint), and a single
dose of at least 1,000 mg of milk, egg or cashew protein (secondary
endpoints) without experiencing moderate to severe allergic
symptoms.
Study results showed a statistically significant higher
proportion of patients (68%) treated with Xolair for 16 to 20 weeks
tolerated at least 600 mg of peanut protein without moderate to
severe allergic symptoms, compared to 5% of those treated with
placebo (p<0.0001). This amount is equivalent to approximately
two and a half peanuts or half a teaspoon of regular peanut
butter.
In addition, a statistically significant higher proportion of
patients treated with Xolair compared to placebo tolerated at least
1,000 mg of protein from milk (66% vs. 11%; p<0.0001), egg (67%
vs. 0%; p<0.0001) or cashew (42% vs. 3%; p<0.0001) without
moderate to severe allergic symptoms. This amount is equivalent to
approximately two tablespoons of 1% milk, one-quarter of an egg or
three and a half cashews. While patients in the study tolerated
these amounts of food, treatment with Xolair should be used with
continued food allergen avoidance.
Safety findings were consistent with the known safety profile of
Xolair across its additional indications and in previous clinical
trials.4 The most common adverse events (≥3% of
patients) in Xolair-treated patients in the study were injection
site reaction (15.5% vs. 10.9% with placebo) and fever (6.4% vs.
3.6% with placebo).
About 3.4 million children and 13.6 million adults in the U.S.
have been diagnosed with IgE-mediated food allergies, based on
estimates for 2024.1,2 Food allergy prevalence has been
on the rise for the past 20 years.5 There are 160
different foods that cause IgE-mediated food allergy.6
Allergic reactions can range from mild to moderate, including hives
and swelling, to severe and life-threatening, such as anaphylaxis.
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.1,2,7
This marks the fourth FDA-approved indication for Xolair across
allergic and inflammatory conditions, including moderate to severe
persistent allergic asthma, chronic spontaneous urticaria (CSU) and
chronic rhinosinusitis with nasal polyps (CRSwNP). Since its
initial approval in 2003, more than 700,000 patients have been
treated with Xolair in the U.S.8
Xolair is a prescription biologic medicine that is given as an
injection under the skin (subcutaneous). It is the only
FDA-approved antibody designed to target and block IgE — an
underlying driver of food allergy reactions. The recommended Xolair
dosage for treatment of food allergy is 75 mg to 600 mg once every
2 or 4 weeks. Xolair dose and dosing frequency is determined by
total serum IgE level and body weight. Injections can be given by a
healthcare provider in a healthcare setting or at home through
self-injection after initiating in a healthcare setting. Healthcare
providers will determine appropriate candidates for
self-injection.
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 Study
The Omalizumab as Monotherapy and as Adjunct Therapy to
Multi-Allergen Oral Immunotherapy in Food Allergic Children and
Adults (OUtMATCH; NCT03881696) study is a 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 food allergens.
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 at baseline.
After 16 to 20 weeks of treatment with Xolair or placebo, each
participant completed four separate blinded food challenges where
they were given gradually increasing amounts of peanut protein, two
other food proteins they were allergic to, and a placebo
ingredient. The food challenges were conducted in a carefully
controlled setting with investigators looking for signs and
symptoms of allergic reaction to assess patients’ ability to
consume a single dose of at least 600 mg of peanut protein (primary
endpoint), and a single dose of at least 1,000 mg of milk, egg,
wheat, cashew, hazelnut or walnut protein (secondary endpoints)
without experiencing dose-limiting symptoms, which were defined as
moderate to severe allergic symptoms, including skin, respiratory
or gastrointestinal symptoms.
The OUtMATCH study is sponsored and funded by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
NIH, and is being conducted by the NIAID-funded Consortium for Food
Allergy Research (CoFAR) at 10 clinical sites across the U.S. led
by Johns Hopkins Children's Center and co-led by Stanford School of
Medicine. The study is also supported by Genentech and Novartis
Pharmaceuticals Corporation.
About Xolair
Xolair is the only approved antibody designed to target and block
immunoglobulin E (IgE). By reducing free 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] Gupta RS, Warren CM, Smith BM, et al. The Public Health Impact
of Parent-Reported Childhood Food Allergies in the United States.
Pediatrics. 2018;142(6):e20181235. doi:10.1542/peds.2018-1235.
[3] Anvari S, Miller J, Yeh Chih-Yin, et al. IgE-Mediated Food
Allergy. Clinical Reviews in Allergy & Immunology.
2019;57:244-260. doi: 10.1007/s12016-018-8710-3.
[4] Xolair (omalizumab) Prescribing Information. Genentech, Inc.
and Novartis Pharmaceuticals Corporation 2024.
[5] Benedé S, Blázquez AB, Chiang D, Tordesillas L, Berin MC. The
Rise of Food Allergy: Environmental Factors and Emerging
Treatments. EBioMedicine. 2016;7:27-34.
[6] US FDA. Food Allergies.
https://www.fda.gov/food/food-labeling-nutrition/food-allergies
Accessed February 2024.
[7] 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.
[8] Data on file (December 2023). Genentech USA, Inc. South San
Francisco, CA.
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