ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
20 Juin 2023 - 2:00PM
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical
company dedicated to empowering at-risk patients and caregivers to
better protect themselves from severe allergic reactions that could
lead to anaphylaxis, today announced that the U.S. Food and Drug
Administration (FDA) extended the Prescription Drug User Fee Act
(PDUFA) target action date by three months for the New Drug
Application (NDA) for
neffy (Intranasal (IN)
Epinephrine) for the treatment of allergic reactions (Type 1),
including anaphylaxis, for adults and children ≥30 kg. The updated
PDUFA target action date is September 19, 2023.
Following a favorable benefit-risk assessment by the FDA
Pulmonary-Allergy Drug Advisory Committee (PADAC) meeting on May
11, 2023, the Agency informed ARS that it requires additional time
to complete its review; however, no additional pre-marketing
studies have been requested and ARS has addressed all other
information requests from the Agency to date. The additional time
is needed for labeling and post-marketing commitment discussions
regarding neffy, and ARS has submitted proposals
for post-marketing commitments based on input from the PADAC
meeting in May.
“FDA is working on labeling and post-marketing commitments as
the final steps in the review process,” said Richard Lowenthal,
Co-Founder, President and Chief Executive Officer, ARS
Pharmaceuticals. “Following the strong endorsement of our clinical
data for neffy at the May PADAC meeting, there was
limited time to address any final questions and complete labeling.
While the Agency extended the PDUFA timeline, we are hopeful that
labeling discussions will be completed as soon as possible given
the significant unmet need in the allergy community for a
needle-free option that is easily carried and administered without
anxiety or hesitation.”
In addition, a marketing authorization application for
neffy is under review by the European Medicines
Agency with a decision expected in early 2024.
For more information, visit: https://ars-pharma.com/
About Type I Allergic Reactions, including
AnaphylaxisType I severe allergic reactions are serious
and potentially life-threatening events that can occur within
minutes of exposure to an allergen and require immediate treatment
with epinephrine, the only FDA-approved medication for these
reactions. While epinephrine autoinjectors have been shown to be
highly effective, there are well published limitations that result
in many patients and caregivers delaying or not administering
treatment in an emergency situation. These limitations include fear
of the needle, lack of portability, needle-related safety concerns,
lack of reliability, and complexity of the devices. There are
approximately 25 to 40 million people in the United States who
experience Type I severe allergic reactions. Of those, only 3.3
million currently have an active epinephrine autoinjector
prescription, and of those, only half consistently carry their
prescribed autoinjector. Even if patients or caregivers carry an
autoinjector, more than half either delay or do not administer the
device when needed in an emergency.
About ARS Pharmaceuticals, Inc.ARS is a
biopharmaceutical company dedicated to empowering at-risk patients
and caregivers to better protect themselves from severe allergic
reactions that could lead to anaphylaxis. The Company is developing
neffy® (also referred to as ARS-1), an intranasal
epinephrine product in clinical development for patients and their
caregivers with Type I allergic reactions including food,
medications and insect bites that could lead to life-threatening
anaphylaxis. For more information, visit www.ars-pharma.com.
Forward-Looking StatementsStatements in this
press release that are not purely historical in nature are
“forward-looking statements'' within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, the anticipated timing for regulatory
review decisions on neffy and the potential
approval of neffy; discussions regarding labeling
and post-marketing commitments with FDA being the final steps in
the review process and labeling discussions being concluded
shortly; potentially bringing to market the first needle-free
treatment option for severe allergic reactions; and other
statements that are not historical fact. Because such statements
are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Words such as “anticipate,” “intends,” “plans,”
“expects,” “will,” “potential” and similar expressions are intended
to identify forward-looking statements. These forward-looking
statements are based upon ARS’s current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, the ability to obtain and maintain
regulatory approval for neffy; the PADAC decision
should not be relied on as an indication
that neffy will ultimately be
approved; the FDA is not bound by the PADAC decision or any of
its recommendations and there are a number of instances where the
FDA has voted against the recommendations of advisory
committees; the PDUFA target action date may be further
delayed due to various factors outside ARS’s control; even
though ARS believes its discussions with the FDA regarding final
labeling and post-marketing commitments are the final steps in the
review process, there is no guarantee that those steps will be
concluded in a manner favorable to ARS and likewise those steps
should not be relied on as an indication that the FDA will
ultimately approve neffy, as the FDA may identify
new issues that could delay or prevent the approval of
neffy; potential safety and other complications
from neffy; the scope, progress and expansion of
developing and commercializing neffy; the size and
growth of the market therefor and the rate and degree of market
acceptance thereof vis-à-vis intramuscular injectable products;
ARS’s ability to protect its intellectual property position; and
the impact of government laws and regulations. Additional risks and
uncertainties that could cause actual outcomes and results to
differ materially from those contemplated by the forward-looking
statements are included under the caption “Risk Factors” in ARS’s
Quarterly Report on Form 10-Q for the quarter ended March 31,
2023, filed with the Securities and Exchange
Commission (“SEC”) on May 15, 2023. This and other
documents ARS files with the SEC can also be accessed on
ARS’s web page at ir.ars-pharma.com by clicking on the
link “Financials & Filings.”
The forward-looking statements included in this press release
are made only as of the date hereof. ARS assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
ARS Investor Contact:Monique AllaireTHRUST Strategic
Communicationsmonique@thrustsc.com
Justin ChakmaARS Pharmaceuticalsjustinc@ars-pharma.com
ARS Media Contact:Laura O'NeillFINN
Partnerslaura.oneill@finnpartners.com
ARS Pharmaceuticals (NASDAQ:SPRY)
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