— Majority of Patients Experienced Low Rates of
Adverse Events, Which Declined in Frequency and Severity with
Continued Treatment —
— Systemic Allergic Reactions and Epinephrine
Use Were Low and Decreased Over Time —
Aimmune Therapeutics, a Nestlé Health Science company developing
and commercializing treatments for potentially life-threatening
food allergies, today announced new clinical data from a pooled
analysis of three controlled phase 3 (PALISADE1, RAMSES, ARTEMIS2)
and three open-label extension (ARC0043, ARC008, ARC011) trials of
PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. These
data will be presented at the American Academy of Allergy, Asthma
& Immunology (AAAAI) Virtual Annual Meeting held February 26 –
March 1, 2021.
In patients with peanut allergy (ages 4 through 17) who
continued daily treatment with PALFORZIA for up to 3.5 years
reported adverse events were mostly mild, occurred early on in
treatment, and declined over the course of treatment. With
longer-term treatment, systemic allergic reactions and epinephrine
use were rare and continued to decrease with treatment.
“As a practicing allergist, I have seen firsthand the burden
that peanut allergy has on children and their families,
significantly restricting their daily activities as they try to
avoid accidental exposure,” said Thomas Casale, MD, lead author of
the analysis and professor of medicine at the University of South
Florida. “These data provide insight into the long-term safety of
PALFORZIA as a treatment option. It also highlights that in these
clinical trials, severe allergic reactions associated with the
treatment were uncommon – potentially a critical factor for
patients and their allergists as they consider PALFORZIA as a
treatment option.”
The findings being presented at AAAAI further build on the full
results from ARC004, the open-label follow-on study to the pivotal
phase 3 PALISADE trial of PALFORZIA, which were published in the
Journal of Allergy & Clinical Immunology: In Practice, on
December 31, 2020, and reported that long-term daily dosing with
PALFORZIA was well tolerated, with no newly identified safety
concerns. Furthermore, the data showed that continued daily
treatment with PALFORZIA beyond one year in peanut-allergic
patients (ages 4 through 17) resulted in sustained efficacy, was
well tolerated with a favorable safety profile, and was associated
with changes in blood levels of peanut-specific immunoglobulin E
(IgE) and immunoglobulin G4 (IgG4) that suggest ongoing
immunomodulation during the second year of treatment with
PALFORZIA. High rates of desensitization were also observed, which
improved over time; desensitization rates were highest in those
receiving daily dosing of PALFORZIA for the longest duration (2
years).
“The pooled safety analysis presented at AAAAI represents the
largest safety data set of patients treated for peanut allergy and
continues to show that long-term daily treatment with PALFORZIA is
well tolerated, with mostly mild to moderate adverse events
occurring primarily during updosing and resolving as the patient
desensitizes to the allergen,” said Stephen Tilles, M.D., Senior
Director, Medical Affairs for Aimmune Therapeutics. “Across these
six trials evaluating more than 1,100 patients, we further saw a
consistent safety profile for PALFORZIA that indicates adverse
events decline in frequency and severity with continued treatment,
providing important insights for allergists, patients and
caregivers to help facilitate discussions and decision-making
around treatment with PALFORZIA.”
These data will be presented online in a poster presentation:
#335: “Safety of Peanut (Arachis Hypogaea) Allergen Powder-dnfp in
Children and Teenagers With Peanut Allergy: Pooled Analysis From
Controlled and Open-Label Phase 3 Trials Over 3.5 Years”, Casale,
T., et al.
Key highlights from the data presentation include:
- More than 3 out of 4 patients were able to achieve the 300mg
maintenance dose of PALFORZIA (n=938), and more than half of all
patients had received at least one year of treatment (n=755) as of
July 31, 2020; 431 and 94 patients across the studies received 2
and 3 years of PALFORZIA treatment, respectively.
- Participants reported mild-to-moderate treatment-related
adverse events (TRAEs) during the updosing phase (26.2% moderate,
57.9% mild) and decreased throughout the maintenance phase (1.4%
moderate, 5.8% mild, at the end of year 3).
- The most frequently reported TRAEs were throat irritation,
abdominal pain, and oral pruritis.
- Overall, 13.3% of trial patients discontinued participation due
to adverse events, with gastrointestinal symptoms as the most
common primary reason for withdrawal, most of which occurred during
the first 6 months.
- Exposure-adjusted rates of systemic allergic reactions of any
severity and epinephrine use were low during Year 1 and decreased
in Years 2 and 3.
- Over a ~3.5-year treatment period, 14 participants (1.2%)
experienced a treatment-related severe systemic allergic
reaction.
PALFORZIA was approved by the U.S. Food and Drug Administration
(FDA) in January 2020 as an oral immunotherapy for the mitigation
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut in patients aged 4 through 17 years
with a confirmed diagnosis of peanut allergy. In December 2020, the
European Commission (EC) approved PALFORZIA for patients aged 4 to
17 years with a confirmed diagnosis of peanut allergy in
conjunction with a peanut-avoidant diet. Additionally, a Swiss
Agency for Therapeutic Products (SwissMedic) review of AR101 is
ongoing.
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut. PALFORZIA is approved for use in
patients with a confirmed diagnosis of peanut allergy. Initial Dose
Escalation may be administered to patients aged 4 through 17 years.
Up-Dosing and Maintenance may be continued in patients 4 years of
age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant
diet.
Limitations of Use: Not indicated for the emergency treatment of
allergic reactions, including anaphylaxis.
IMPORTANT SAFETY INFORMATION
Boxed WARNING:
PALFORZIA can cause anaphylaxis, which may be life
threatening and can occur at any time during PALFORZIA
therapy.
Prescribe injectable epinephrine, instruct and train patients
on its appropriate use, and instruct patients to seek immediate
medical care upon its use.
Do not administer PALFORZIA to patients with uncontrolled
asthma.
Dose modifications may be necessary following an anaphylactic
reaction.
Observe patients during and after administration of the
Initial Dose Escalation and the first dose of each Up-Dosing level,
for at least 60 minutes.
PALFORZIA is available only through a restricted program
called the PALFORZIA REMS.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled
asthma, or with a history of eosinophilic esophagitis and other
eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
Anaphylaxis
PALFORZIA can cause anaphylaxis, which may be life threatening.
PALFORZIA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA
REMS because of the risk of anaphylaxis. Only prescribers,
healthcare settings, pharmacies, and patients certified and
enrolled in the REMS Program can prescribe, receive, dispense or
administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA
dosing, including Maintenance and in subjects who have undergone
recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had
severe or life-threatening anaphylaxis within the previous 60 days.
PALFORZIA may not be suitable for patients with certain medical
conditions that may reduce the ability to survive anaphylaxis,
including but not limited to markedly compromised lung function,
severe mast cell disorder, or cardiovascular disease. In addition,
PALFORZIA may not be suitable for patients taking medications that
can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each
Up-Dosing level must be administered in a certified health care
setting.
Patients may be more likely to experience allergic reactions
following PALFORZIA administration in the presence of cofactors
such as exercise, hot water exposure, intercurrent illness (e.g.,
viral infection), or fasting. Other potential cofactors may include
menstruation, sleep deprivation, nonsteroidal anti-inflammatory
drug use, or uncontrolled asthma. Patients should be proactively
counseled about the potential for the increased risk of anaphylaxis
in the presence of these cofactors. If possible, adjust the time of
dosing to avoid these cofactors. If it is not possible to avoid
these cofactors, consider withholding PALFORZIA temporarily.
Asthma
Uncontrolled asthma is a risk factor for a serious outcome,
including death, in anaphylaxis. Ensure patients with asthma have
their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is
experiencing an acute asthma exacerbation. Following resolution of
the exacerbation, resumption of PALFORZIA should be undertaken
cautiously. Re-evaluate patients who have recurrent asthma
exacerbations and consider discontinuation of PALFORZIA.
Eosinophilic Gastrointestinal Disease
Discontinue PALFORZIA and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent
gastrointestinal symptoms, including dysphagia, vomiting, nausea,
gastroesophageal reflux, chest pain, or abdominal pain.
Gastrointestinal Adverse Reactions
Gastrointestinal adverse reactions were commonly reported in
PALFORZIA-treated subjects, and dose modification should be
considered for patients who report these reactions. For severe or
persistent gastrointestinal symptoms consider a diagnosis of
eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse events reported in subjects treated with
PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal
pain, vomiting, nausea, oral pruritus, oral paresthesia, throat
irritation, cough, rhinorrhea, sneezing, throat tightness,
wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and
ear pruritus.
Please see full Prescribing Information, including Boxed
WARNING, and Medication Guide at www.PALFORZIA.com.
For more information about PALFORZIA, please call 1-844-PALFORZ
(1-844-725-3679) or visit www.PALFORZIA.com.
About Aimmune
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is
a biopharmaceutical company developing and commercializing
treatments for potentially life-threatening food allergies and
other food-mediated conditions, including gastrointestinal
conditions. Aimmune has one FDA- and EU-approved medicine for
peanut allergy and other investigational therapies in development.
For more information, please visit www.aimmune.com.
About Nestlé Health Science
Nestlé Health Science (NHSc), a wholly owned subsidiary of
Nestlé, is a globally recognized leader in the field of nutritional
science. At NHSc we are committed to empowering healthier lives
through nutrition for consumers, patients and their healthcare
partners. We offer an extensive consumer health portfolio of
industry-leading medical nutrition, consumer and vitamins, minerals
and supplements (VMS) brands that are science-based solutions
covering all facets of health from prevention, to maintenance, all
the way through to treatment. NHSc is redefining the way we
approach the management of health in several key areas such as
pediatric health, allergy, acute care, oncology, metabolic health,
healthy aging, gastrointestinal health, and inborn errors of
metabolism. Headquartered in Switzerland, NHSc employs over 5,000
people around the world who are committed to making a difference in
people's lives, for a healthier today and tomorrow.
www.nestlehealthscience.com.
PALFORZIA®, AIMMUNE® and AIMMUNE THERAPEUTICS® are trademarks of
Aimmune Therapeutics, Inc.
1 N Engl J Med. 2018;379(21):1991-2001. 2 Lancet Child Adolesc
Health. 2020;4(10):728-739. 3 Allergy Clin Immunol Pract.
2020;S2213-2198(20):31361-1.
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U.S. Media: Jodi Sievers +1 (628) 250-6849
jsievers@aimmune.com
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Europe Media: Sophie Shey +44 7964 560008
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