CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
18 Novembro 2020 - 10:30AM
CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of infectious and inflammatory
disease, today announced that the U.S. Food and Drug Administration
(FDA) has decided to cancel the Antimicrobial Drug Advisory
Committee meeting tentatively scheduled for January 14, 2021 to
discuss the New Drug Application (NDA) for Defencath®. When the FDA
accepted for filing the Company’s submitted NDA and granted
priority review, it set a Prescription Drug User Fee Act (PDUFA)
date of February 28, 2021 for the completion of its review for
approval of the NDA. The Agency noted that it was planning to hold
an advisory committee meeting to discuss the application for
Defencath to be used as a catheter lock solution in hemodialysis
patients for the prevention of catheter related blood stream
infections (CRBSI) and that it had not identified any potential
review issues at that time. CorMedix has been notified that based
on the Agency’s ongoing dialogue with the Company, discussion at an
advisory committee is not needed, and it will continue to work on
the application with CorMedix during the remainder of the review
cycle.
Khoso Baluch, CorMedix CEO commented, “We are
very happy with the level of engagement between FDA and the
CorMedix team during the NDA review process. We look forward to
completion of the review of the NDA and are considering all
strategic options to be able to successfully bring Defencath to the
U.S. market as soon as possible.”
Phoebe Mounts, CorMedix Executive Vice President
and General Counsel, further added, “It is gratifying that the
tremendous effort of the CorMedix team has resulted in continuing
progress with the FDA in the review of the NDA and that the
decision was made that no discussion with an advisory committee is
needed. We intend to continue our effort and dialogue with the
Agency to ensure that the priority review process can be completed
expeditiously to address the unmet medical need of hemodialysis
patients for an antimicrobial catheter lock solution to prevent
life-threatening CRBSI.”
About CorMedix
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of infectious and inflammatory
diseases. The Company is focused on developing its lead product
Defencath®, a novel, antibacterial 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,
which provides 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 intends to develop
Defencath as a catheter lock solution for use in oncology and total
parenteral nutrition patients. It is leveraging its taurolidine
technology to develop a pipeline of antimicrobial medical devices,
with programs in surgical sutures and meshes, and topical
hydrogels. The Company is also working with top-tier researchers to
develop taurolidine-based therapies for rare pediatric cancers.
Neutrolin™ is CE Marked and marketed in Europe and other
territories as a medical device. 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 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, future financial position, financing plans, future
revenues and projected costs 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 results of our discussions with the FDA
regarding the Defencath development path, including whether a
second Phase 3 clinical trial will be required for approval of
Defencath’s marketing approval; the resources needed to secure
approval of the new drug application for Defencath from the FDA;
the risks and uncertainties associated with CorMedix’s ability to
manage its limited cash resources and the impact on current,
planned or future research, including the continued development of
Defencath/Neutrolin and research for additional uses for
taurolidine; 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. At this time, we are unable to
assess whether, and to what extent, the uncertainty surrounding the
Coronavirus pandemic may impact our business and operations. 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 (AMEX:CRMD)
Gráfico Histórico do Ativo
De Jan 2025 até Fev 2025
CorMedix (AMEX:CRMD)
Gráfico Histórico do Ativo
De Fev 2024 até Fev 2025