CorMedix plans to resubmit DefenCath NDA by middle of May

CorMedix announced that following its Type A meeting with the FDA, the Company intends to resubmit its New Drug Application for DefenCath by the middle of May. More specifically: At the Type A meeting, the FDA informed CorMedix that it is in receipt of the close out report for inspectional observations received from its existing contract manufacturing organization, and NDA resubmission with CMO 1 can be done at the Company’s discretion. The FDA may conduct a pre-approval inspection at the facility as part of the NDA review process. Based on guidance from FDA, CorMedix will resubmit the NDA with manufacturing data generated at CMO 1 and utilizing both the existing source of heparin API as well as a new supplier of Heparin API. The Company has completed the validation of the manufacturing process using API 2, and believes all batches have met product specifications. Data for submission are currently available and resubmission is targeted for mid-May following receipt of final Type A meeting minutes. As part of validation of manufacturing with this API, the Company will be adding a 3 mL single-dose vial to its 5 mL commercial presentation to meet market preferences and demand. As the submission will contain new manufacturing information, the Company expects it to be classified as a Class 2 resubmission with a 6-month review. In addition, CorMedix today announced that following the submission of a duplicate New Technology Add-On Payment application in Q4 to the Centers for Medicare & Medicaid Services, CMS has subsequently issued the Inpatient Prospective Payment System 2024 proposed rule that includes a NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP represents reimbursement to inpatient facilities of 75% of the anticipated WAC price of $1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS rule will be published in late summer and we expect this payment amount to be issued in that final rule. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.