Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
12 Giugno 2023 - 2:01PM
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, today announced that the U.S. Food
and Drug Administration (FDA) has acknowledged that its New Drug
Application (NDA) resubmission for vonoprazan, a novel
first-in-class potassium-competitive acid blocker (PCAB), for the
treatment of Erosive GERD (gastroesophageal reflux disease)
constitutes a complete response to the February 2023 complete
response letter (CRL). The FDA has classified this as a Class 2
resubmission and assigned a Prescription Drug User Fee Act (PDUFA)
goal date of November 17, 2023.
“We are thrilled to announce the FDA has set a PDUFA goal date
of November 17, 2023, for our Erosive GERD NDA and has acknowledged
that our resubmission responds to the nitrosamine related issues
cited in the complete response letter we received earlier this year
and allows the Agency to continue its review of our NDA,” said
Terrie Curran, President and Chief Executive Officer of Phathom.
“This significant milestone brings us one step closer to the
approval of a new class of treatment for Erosive GERD representing
the first major innovation to the U.S. GERD market in over 30
years. We eagerly await the potential approval of vonoprazan and
the combined launch of both Erosive GERD and H. pylori indications
in the fourth quarter.”
The NDA resubmission, which was submitted in response to the CRL
issued by the FDA in February 2023, contained three months of
stability data of reformulated vonoprazan tablets to support the
commercial shelf life of vonoprazan. Phathom will continue to
provide additional stability data during the regulatory review as
previously agreed with FDA as part of this resubmission.
About Erosive GERDErosive GERD
(gastroesophageal reflux disease), also known as Erosive
Esophagitis, is a major type of GERD characterized by erosions in
the gastric mucosa caused by acidic reflux of stomach contents into
the esophagus. There are estimated to be over 65 million
individuals with GERD in the U.S., of which approximately 30% have
Erosive GERD. In addition to experiencing troubling heartburn
symptoms, patients with inadequately treated Erosive GERD may
progress to more severe diseases including Barrett’s esophagus and
esophageal cancer.
About Phathom PharmaceuticalsPhathom
Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of novel treatments for
gastrointestinal diseases. Phathom has in-licensed the exclusive
rights in the United States, Europe, and Canada to vonoprazan, a
first-in-class potassium-competitive acid blocker (PCAB). For more
information about Phathom, visit the Company’s website
at www.phathompharma.com and follow the
Company on LinkedIn and Twitter.
Forward Looking StatementsThis press release
contains forward-looking statements. Investors are cautioned not to
place undue reliance on these forward-looking statements, including
statements about the potential of vonoprazan as a treatment for
Erosive GERD and H. pylori; Phathom’s expectations that the
stability data will support the requested shelf life of 24 months;
the timing of potential approval of the NDA; and the timing of a
U.S. commercial launch for Erosive GERD and H. pylori indications.
The inclusion of forward-looking statements should not be regarded
as a representation by Phathom that any of its plans will be
achieved. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in
Phathom’s business, including, without limitation: the FDA may
determine that the NDA resubmission does not adequately address the
deficiencies raised in the CRL; future data generated from our
stability program may be different from the data generated to date
and may not demonstrate that our mitigation efforts will meet the
acceptable intake (AI) of the nitrosamine impurity, or reduce the
impurity to an acceptable level throughout the six-month period
required by FDA or the shelf life of the product, to obtain
approval for its Erosive GERD NDA or to bring vonoprazan to market
for patients with Erosive GERD, if approved, or for patients with
H. pylori, if our anticipated supplements to NDAs are approved;
prior to commercial launch of the H. pylori convenience packs,
Phathom must submit post approval supplements to the relevant NDAs
and Phathom may not submit such supplements on the timeframe it
expects and the FDA may not approve such supplements to the H.
pylori convenience pack NDAs; risks associated with product
manufacturing or formulation changes required to be made in
connection with achieving the AI; the FDA may disagree that the
existing safety and efficacy data, together with additional data,
is sufficient to approve the Erosive GERD NDA or supplements to the
H. pylori NDAs; the inherent risks of clinical development of
vonoprazan; Phathom’s dependence on third parties in connection
with product manufacturing, research and preclinical and clinical
testing; regulatory developments in the United States and foreign
countries; unexpected adverse side effects or inadequate efficacy
of vonoprazan that may limit its development, regulatory approval
and/or commercialization, or may result in recalls or product
liability claims; Phathom’s ability to access additional capital
under its term loan facility and royalty interest finance
agreements is subject to certain conditions; Phathom’s ability to
obtain and maintain intellectual property protection for
vonoprazan; Phathom’s ability to comply with its license agreement
with Takeda; and other risks described in the Company’s prior press
releases and the Company’s filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s Annual Report on Form 10-K and any subsequent filings
with the SEC. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and Phathom undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement, which is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
MEDIA CONTACTNick
Benedetto1-877-742-8466media@phathompharma.com
INVESTOR CONTACTEric
Sciorilli1-877-742-8466ir@phathompharma.com
© 2023 Phathom Pharmaceuticals. All rights reserved.
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