CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath
21 Junio 2023 - 7:30AM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for the
prevention and treatment of life-threatening diseases and
conditions, today announced that the resubmission of the New Drug
Application (NDA) for DefenCath has been accepted for filing by the
U.S. Food and Drug Administration (FDA). The Agency considers the
resubmission as a complete, Class 2 response with a six-month
review, and has assigned a Prescription Drug User Fee Act (PDUFA)
target action date of November 15, 2023.
DefenCath is being developed as a catheter lock
solution with an initial indication of use for the reduction of
catheter-related bloodstream infections (CRBSIs) in patients with
kidney failure who are receiving chronic hemodialysis via a central
venous catheter.
Joe Todisco, Chief Executive Officer of
CorMedix, commented, “the acceptance of our DefenCath NDA
resubmission marks an important milestone for CorMedix as we
continue to work toward our efforts to reduce the risks associated
with receiving hemodialysis via a central venous catheter. We
appreciate the hard work of the broader CorMedix team as well as
our strategic partners. As CorMedix continues to ramp up our
preparations for a potential commercial launch, we expect to
provide additional updates over the coming months.”
About CorMedix
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of life-threatening conditions and
diseases. The Company is focused on developing its lead product
DefenCath™, a novel, non-antibiotic antimicrobial and antifungal
solution designed to prevent costly and life-threatening
bloodstream infections associated with the use of central venous
catheters in patients undergoing chronic hemodialysis. DefenCath
has been designated by FDA as Fast Track and as a Qualified
Infectious Disease Product (QIDP), and the original New Drug
Application (NDA) received priority review in recognition of its
potential to address an unmet medical need. QIDP provides for an
additional five years of marketing exclusivity, which will be added
to the five years granted to a New Chemical Entity upon approval of
the NDA. CorMedix also committed to conducting a clinical study in
pediatric patients using a central venous catheter for hemodialysis
when the NDA is approved, which will add an additional six months
of marketing exclusivity when the study is completed. The Company
received a second Complete Response Letter from the FDA last August
related to deficiencies at both its primary contract manufacturer
and its supplier of heparin API for an unrelated product. After
receiving guidance from FDA at a meeting in April of 2023, the NDA
for DefenCath was resubmitted. CorMedix also intends to develop
DefenCath as a catheter lock solution for use in other patient
populations, and the Company is working with top-tier researchers
to develop taurolidine-based therapies for rare pediatric cancers.
For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are subject to risks and uncertainties. All
statements, other than statements of historical facts, regarding
management’s expectations, beliefs, goals, plans or CorMedix’s
prospects, including, but not limited to, statements regarding the
PDUFA target action date, the timing or ultimate outcome of FDA’s
review, CorMedix’s commercial launch efforts, CorMedix’s future
financial position, financing plans, future revenues, projected
costs and the sufficiency of our cash and short-term investments to
fund our operations should be considered forward-looking. Readers
are cautioned that actual results may differ materially from
projections or estimates due to a variety of important factors,
including: the costs associated with CorMedix’s launch efforts; the
risks and uncertainties of the relationships with the additional
CMO and supplier of heparin; the risks and uncertainties associated
with CorMedix’s ability to manage its limited cash resources and
the impact on current, planned or future research; obtaining
additional financing to support CorMedix’s research and development
and clinical activities and operations; preclinical results are not
indicative of success in clinical trials and might not be
replicated in any subsequent studies or trials; and the ability to
retain and hire necessary personnel to staff our operations
appropriately. These and other risks are described in greater
detail in CorMedix’s filings with the SEC, copies of which are
available free of charge at the SEC’s website at www.sec.gov or
upon request from CorMedix. CorMedix may not actually achieve the
goals or plans described in its forward-looking statements, and
investors should not place undue reliance on these statements.
CorMedix assumes no obligation and does not intend to update these
forward-looking statements, except as required by law.
Investor Contact:Dan FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CorMedix (NASDAQ:CRMD)
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