CorMedix Inc. (CRMD) recently came up announcing acceptance of its product by the U.S. Food and Drug Administration (FDA). The drug administrator allowed submission of product at New Drug Application (NDA) for filing. CorMedix is a developer and manufacturer of therapeutic products especially providing prevention and treatment of inflammatory and infectious diseases. Defencath is the company’s candidate for the prevention of catheter related blood stream infections (CRBSI). It will provide hemodialysis patients with a preventing drug that works as a catheter lock solution.
Previously, the FDA has accorded Defencath with a rotation-based submission and review. CorMedix completed that rolling submission at the end of June. The federal agency also set February 28, 2021 as date for company to proceed further to get approval of the NDA. Before that set date, the new drug will go through a Prescription Drug User Fee Act (PDUFA) review on priority basis.
The FDA is also intending holding a meeting of advisory committee to discuss the application. The Agency also noted that no issues have been identified in potential review at the moment.
Drug making companies carry on developing therapeutic solutions for diagnosis, treatment or prevention of serious conditions. Those solutions have ability far above than the standard applications to significantly improve the therapy practices. To make those effective drugs available to the patients sooner, the FDA grants review of those drug applications on priority basis.
Currently, hemodialysis patients have to experience CBRSI and have been treated with heparin as standard therapy. LOCK-IT-100 trial of Defencath demonstrated a high safety profile and significantly reduced ratio of 71% (p-0.0006) of CRBSI in such patients. And CorMedix included positive results, of 795 such patients who went through those trials, in its filing of Defencath at NDA. For the reason the new drug has been put on the Fast track by FDA. The Agency also designated the drug as Qualified Infectious Disease Product (QIDP). This also makes the drug eligible to request the NDA for a priority review.