The date of the PDUFA remains February 28, 2021
Potentially the first antibacterial and antifungal catheter locking solution in the United States to prevent the catheter Related infections in hemodialysis patients
BERKELEY HEIGHTS, NJ, Nov. 18, 2020 (GLOBE NEWSWIRE) – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on the development and commercialization of therapeutics for the prevention and treatment of infectious and inflammatory diseases, has announced today that the United States 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 agreed to file the company’s submitted NDA and granted priority review, it set February 28, 2021 as the Prescription Drug User Fee Act (PDUFA) date for the completion of its review for the drug. approval of the NDA. The Agency noted that it was planning to hold an advisory committee meeting to discuss the request for the use of Defencath as a catheter locking solution in hemodialysis patients for the prevention of catheter-related bloodstream infections (CRBSI ) and that she had not identified any potential to investigate the issues at that time. CorMedix has been advised that based on the Agency’s continued dialogue with the Company, no discussion in an advisory committee is necessary, and it will continue to work on the application with CorMedix during the remainder of the cycle. exam.
Khoso Baluch, CEO of CorMedix, commented: “We are very pleased with the level of engagement between the FDA and the CorMedix team during the NDA review process. We look forward to the completion of the NDA review and are considering all strategic options to be able to successfully bring Defencath to the US market as soon as possible.
Phoebe Mounts, Executive Vice President and General Counsel, CorMedix, added, “It is gratifying that the tremendous efforts of the CorMedix team have allowed continued progress with the FDA in reviewing the NDA and that ‘It was decided that no discussion with an advisory committee is necessary. We intend to continue our efforts and dialogue with the Agency to ensure that the priority review process can be completed quickly to address the unmet medical need of hemodialysis patients for an antimicrobial catheter lock solution. to prevent life-threatening CRBSIs.
CorMedix Inc. is a biopharmaceutical company focused on the development and commercialization of therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on the development of its flagship product Defencath®, a novel antibacterial and antifungal solution designed to prevent costly and life-threatening blood infections associated with the use of central venous catheters in patients on chronic hemodialysis. Defencath has been designated by the FDA as a Fast Track and Qualified Infectious Disease Product, which provides an additional five years of market exclusivity, in addition to the five years granted to a new chemical entity after NDA approval. CorMedix also intends to develop Defencath as a catheter locking solution for patients in oncology and total parenteral nutrition. It is leveraging its taurolidine technology to develop an antimicrobial medical device pipeline, with programs of surgical sutures and mesh and topical hydrogels. The Company is also working with leading 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which are subject to risks and uncertainties. All statements, other than statements of historical fact, regarding CorMedix’s expectations, beliefs, objectives, plans or prospects, future financial condition, financing plans, future revenues and projected costs of management should be viewed as prospective. 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 path to development of Defencath, including whether a second phase clinical trial 3 will be required for the approval of the marketing authorization for Defencath; the resources required to obtain approval of the new drug application for Defencath from the FDA; 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 the search for additional uses for taurolidine; securing additional funding to support CorMedix research and development as well as clinical activities and operations; preclinical results do not indicate the success of clinical trials and may not be replicated in subsequent studies or trials; and the ability to retain and hire the 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 more detail in CorMedix’s filings with the SEC, copies of which are available free of charge on the SEC’s website at www.sec.gov or on request from CorMedix. . CorMedix may not achieve the objectives or plans described in its forward-looking statements, and investors should not place undue reliance on such statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.