-- Important Data on Psychosocial Burden of
Peanut Allergy on Children and Caregivers Also to be Presented
--
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing and commercializing treatments for
life-threatening food allergies, today announced it will present
important new long-term safety, efficacy and immunological data
from ARC004, an open-label, rollover study of the landmark pivotal
PALISADE trial of PALFORZIA™ [Peanut (Arachis hypogaea) Allergen
Powder-dnfp] and data on patient-reported treatment satisfaction
from the European phase 3 ARTEMIS trial of PALFORZIA. In addition,
insights from the PAPRIQUA study about the psychosocial burden of
peanut allergy on children and their caregivers will be presented.
These data will be presented at the European Academy of Allergy and
Clinical Immunology (EAACI) Digital Congress to be held from June
6-8.
“We are presenting the longest follow-up data on the safety,
efficacy and immunomodulation associated with daily dosing of
PALFORZIA, as well as insights into patient satisfaction with
PALFORZIA treatment, the first peanut allergy treatment approved by
the U.S. Food and Drug Administration,” said Daniel Adelman, M.D.,
Chief Medical Officer of Aimmune. “Additionally, new insights about
the daily burden of living with peanut allergy will be presented to
highlight the need for an approved treatment for peanut allergy. To
that end, we take great pride in our leadership and dedication to
improving the lives of those affected by peanut allergy.”
The following abstracts will be available , for on-demand
viewing on the EAACI scientific programme website starting at
9:00am CEST / 3:00am EDT on Saturday, June 6, 2020
PALFORZIA Clinical Trial Data
- 1230: Sharma et al., Treatment Satisfaction with AR101 Oral
Immunotherapy for Peanut Allergy in a European Paediatric
Population
- 1393: Fernández-Rivas et al., PALISADE Follow-On Study
(ARC004): Longer-Term Outcomes with AR101 Oral Immunotherapy for
Peanut Allergy
Peanut Allergy Data
- 243: Acaster et al., Peanut Allergy impact on PRoductivity and
QUAlity of life (PAPRIQUA): The Psychosocial Impact of Peanut
Allergy in Children and Caregivers
Additional Data Involving PALFORZIA
- 1343: Wambre et al., Baseline characteristics of
peanut-allergic individuals during the dupilumab as adjunct to
AR101 clinical trial
PALFORZIA (previously known as AR101) 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 the United States in patients with
a confirmed diagnosis of peanut allergy. In Europe, Aimmune has a
marketing authorization application for AR101 (PALFORZIA) under
review with the European Medicines Agency (EMA).
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 Therapeutics
Aimmune Therapeutics, Inc. is a biopharmaceutical company
developing and commercializing treatments for potentially
life-threatening food allergies. With a mission to improve the
lives of people with food allergies, Aimmune is developing and
commercializing oral treatments for potentially life-threatening
food allergies. The Company’s Characterized Oral Desensitization
ImmunoTherapy (CODIT™) approach is intended to provide meaningful
levels of protection against allergic reactions resulting from
accidental exposure to food allergens by desensitizing patients
with defined, precise amounts of key allergens. Aimmune has one
FDA-approved medicine for peanut allergy, a marketing authorization
application under review with the European Medicines Agency (EMA)
for its investigational medicine for peanut allergy, and other
investigational therapies in development to treat other food
allergies. For more information, please visit www.aimmune.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding:
Aimmune’s expectations regarding the upcoming presentation of data
at the EAACI Digital Congress, including data regarding safety,
efficacy, patient and caregiver experience of living with peanut
allergy, and patient satisfaction with PALFORZIA treatment; and
Aimmune’s expectations regarding potential applications of the
CODIT approach to treating life-threatening food allergies. Risks
and uncertainties that contribute to the uncertain nature of the
forward-looking statements include the risk that the COVID-19
worldwide pandemic may continue to negatively impact the business,
research and clinical operations of Aimmune or its partners;
Aimmune’s or any of its collaborative partners’ ability to initiate
and/or complete clinical trials; the unpredictability of the
regulatory process; the possibility that Aimmune’s or any of its
collaborative partners’ clinical trials will not be successful;
Aimmune’s dependence on the success of PALFORZIA; Aimmune’s
reliance on third parties for the manufacture of Aimmune’s products
and product candidates; possible regulatory developments in the
United States and foreign countries; and Aimmune’s ability to
attract and retain senior management personnel. These and other
risks and uncertainties are described more fully in Aimmune's most
recent filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. All forward-looking statements contained in this
press release speak only as of the date on which they were made.
Aimmune undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
This press release concerns PALFORZIA (AR101), which has been
approved for marketing by the FDA in the United States and has not
been approved for marketing by the EMA or Swissmedic. AR101 in
Europe is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.
PALFORZIA™, AIMMUNE™, AIMMUNE THERAPEUTICS™ and CODIT™ are
trademarks of Aimmune Therapeutics, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200601005148/en/
Investors: DeDe Sheel (917) 834-1494
dsheel@aimmune.com
Media: Julie Normart (559) 974-3245 jnormart@w2ogroup.com
Lauren Barbiero (646) 564-2156 lbarbiero@w2ogroup.com
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From Jul 2023 to Jul 2024