ARS Pharmaceuticals Announces FDA Advisory Committee for neffy® for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
SAN DIEGO, March 28, 2023 (GLOBE NEWSWIRE) -- 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) has scheduled a Division of Pulmonology, Allergy and Critical Care Advisory Committee meeting on May 11, 2023 to review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis.
The FDA stated the following regarding an Advisory Committee in its official pre-NDA meeting minutes received by ARS:
“The majority of patients with type I allergic reactions including anaphylaxis have limited or unsatisfactory treatment options in real-world community settings because of reluctance to administer or carry their injectable epinephrine devices,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “The announcement to hold an Advisory Committee is in-line with our historical interactions with the FDA over the years, and we believe a positive step towards the potential approval of neffy. We are excited to have the opportunity to discuss neffy with the FDA and the Advisory Committee.”
The Company’s NDA submission for neffy was accepted for review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date anticipated in mid-2023.
About Type I Allergic Reactions including Anaphylaxis
About ARS Pharmaceuticals, Inc.
Statements 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; the implications of the FDA scheduling an Advisory Committee meeting, including ARS’s belief that it reflects a positive step towards the potential approval of neffy; the timing of the Advisory Committee Meeting; the estimated addressable patient population for neffy; 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,” “believe,” “plan,” “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 FDA’s scheduling of an Advisory Committee meeting should not be relied on as an indication that neffy will ultimately be approved, and there are multiple examples of the FDA scheduling advisory committee meetings for product candidates that were not ultimately approved; the outcome of the Advisory Committee is uncertain and it is possible that the Advisory Committee will have an adverse or split recommendation with respect to neffy; even if the Advisory Committee recommends the approval of neffy, the FDA is not bound by the Advisory Committee’s recommendation; the PDUFA target action date may be delayed due to various factors outside ARS’s control; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing neffy, if approved; 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; the impact of government laws and regulations; and ARS’s ability to execute its plans and strategies. 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 the company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 23, 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.
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