U.S. FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy
March 18 2019 - 8:00AM
Business Wire
-- If Approved, AR101 Will Be the First
Medicine for This Life-Threatening Condition --
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing treatments for life-threatening food allergies,
today announced that the Biologics License Application (BLA) for
AR101 has been accepted for review by the U.S. Food and Drug
Administration (FDA).
“Today is a significant milestone for Aimmune. The FDA’s
acceptance of our BLA is a crucial step forward in delivering AR101
to children, teens and families living with the serious, daily risk
of allergic reactions to accidental exposure to peanuts,” said
Jayson Dallas, M.D., President and Chief Executive Officer of
Aimmune. “We are working with the FDA to complete their review as
expeditiously as possible given that there are currently no
approved medicines for peanut allergy.”
Aimmune is developing AR101 as a treatment to reduce the risk of
anaphylaxis following accidental exposure to peanut. The FDA
granted AR101 Breakthrough Therapy Designation in June 2015 for
peanut-allergic children and adolescents ages 4-17, which was
preceded by the granting of Fast Track Designation in September
2014. Both of these programs support expedited review of new drugs
and biologics.
The FDA has informed Aimmune that the BLA will be reviewed under
a twelve-month target review period, as measured from the January
2019 start date. As a consequence, review of the BLA may take until
late January 2020. Aimmune is currently engaged in discussions with
the FDA regarding the review timeline for the AR101 BLA. The FDA
expects to convene an advisory committee meeting to discuss the
application.
“Every day in the United States, more than one million children
and teens with peanut allergy are at risk that exposure to food
allergens could lead to potentially life-threatening reactions,”
said Daniel Adelman, M.D., Chief Medical Officer of Aimmune.
“Published epidemiologic studies and everyday experiences of this
community show that for many, avoidance of peanuts is not enough.
There is an urgent need for a rigorously developed, clinically
proven medicine like AR101 that can help protect people when
accidental exposures do occur.”
Aimmune’s BLA is comprised of extensive clinical as well as
chemistry, manufacturing and controls (CMC) data. Specifically,
data from the pivotal phase 3 PALISADE trial of AR101, the largest
and only successful phase 3 trial in peanut allergy, were published
in the New England Journal of Medicine and demonstrated that AR101
treatment resulted in a significant increase in the amount of
peanut protein tolerated compared to placebo. The data suggest that
AR101-treated patients could expect fewer and less severe reactions
to accidental peanut exposures. Data from the phase 3 RAMSES trial
confirmed the safety profile of AR101 first observed in the
PALISADE study; both trials are part of the application
submission.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company
developing oral treatments for 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’s first investigational biologic product, AR101
is being developed as a treatment to reduce the risk of anaphylaxis
following accidental exposures to peanut. AR101 has received the
FDA’s Breakthrough Therapy Designation for the desensitization of
peanut-allergic patients 4-17 years of age. Aimmune expects to file
for marketing approval of AR101 in Europe mid-2019. Aimmune has
filed an IND application for its second product, AR201, for the
treatment of egg allergy and intends to start a randomized Phase 2
clinical trial mid-2019. For more information, please see
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 potential benefits of AR101;
Aimmune’s expectations regarding the applicable review period of
the BLA for AR101; Aimmune’s expectations regarding the planned
timing and filing for marketing approval of AR101 in Europe;
Aimmune’s expectations on the timing of initiating a Phase 2
clinical trial for AR201; 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 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 AR101; 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 Annual Report on Form 10-K for
the year ended December 31, 2018. 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 AR101, a product candidate that is
under clinical investigation. AR101 has not been approved for
marketing by the FDA or the European Medicines Agency (EMA). AR101
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190318005268/en/
Investors:Eric Bjerkholt(650) 376-5582
orebjerkholt@aimmune.com
Media:Alison Marquiss(650) 376-5583
oramarquiss@aimmune.com
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