CorMedix · DefenCath · Aug 2022
How did CorMedix describe the FDA's second letter?
The 8-K said the letter cited no deficiencies other than those at the manufacturer and the heparin supplier. The letter also found the name Defencath unacceptable; the press release does not mention the name.
EphemerisX Research · Published · 4 source documents · 2 min read
Short answer
The August 8, 2022 press release said approval awaited resolution of inspection deficiencies at the contract manufacturer and the heparin supplier, and that the letter cited no other deficiencies. The letter's numbered items also include labeling, carton labeling and a finding that the name Defencath was unacceptable; the press release does not mention the name. It also announced Alcami as an alternative manufacturing site.
What the evidence shows
The 8-K: the NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA
8-K · Aug 9, 2022. There were no other deficiencies related to DefenCath cited in the CRL
8-K · Aug 9, 2022.
The letter's first item names Rovi and a redacted second facility: our field investigators conveyed deficiencies to the representatives of the facilities
FDA · Aug 4, 2022 · p. 2. Neither press release reporting a letter (March 2021, August 2022) names Rovi, the facility both FDA letters name. 8-K · searched Its fourth item, under the heading for the proprietary name: This proposed name is unacceptable due to confusion with another product that is also under review
FDA · Aug 4, 2022 · p. 4. The August 2022 press release does not mention the proprietary name or the letter's finding on it. 8-K · searched The CEO is quoted saying he was encouraged to have substantive labeling and clinical review completed by FDA
8-K · Aug 9, 2022.
On heparin, the 8-K says the FDA conducted a recent inspection unrelated to DefenCath at the facility of the company’s heparin supplier, which culminated in the API supplier receiving a warning letter as a result of manufacturing deficiencies for a non-heparin API
8-K · Aug 9, 2022, and that by way of the CRL, the FDA has now informed the company that satisfactory resolution of these deficiencies will be required
8-K · Aug 9, 2022. The letter refers to an inspection of manufacturing facilities for this application
FDA · Aug 4, 2022 · p. 2.
On the main manufacturer, The FDA has not yet advised the CMO of the post-inspection compliance classification
8-K · Aug 9, 2022, and the inspectional deficiencies at these manufacturing facilities could not be resolved prior to the PDUFA date
8-K · Aug 9, 2022. The company also announced Alcami, which will serve as an alternative manufacturing site for DefenCath
8-K · Aug 9, 2022. What became of Alcami: Which manufacturer was DefenCath approved with, and what happened to the alternatives?
The cover 8-K, filed August 9: August 8, 2022, CorMedix Inc.
8-K · Aug 9, 2022 issued a press release announcing that a second Complete Response Letter was received
8-K · Aug 9, 2022.
Follow the thread
- How did CorMedix describe the FDA's first letter?Neither press release names Rovi
- What did CorMedix say it fixed before resubmitting DefenCath in 2022?The scheduled inspection, and what it found
- How did a heparin supplier's warning letter for another product hold up DefenCath?A warning letter for a non-heparin API
- Which manufacturer was DefenCath approved with, and what happened to the alternatives?Alcami as an alternative site
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, Outlook Therapeutics, Replimune, Verrica Pharmaceuticals
- What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Cross-investigation · Regulatory pathway · with Aldeyra Therapeutics, Outlook Therapeutics, Replimune
- What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with Verrica Pharmaceuticals
- What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with Replimune, Verrica Pharmaceuticals
The documents, by date
The passages quoted
CorMedix Form 8-K, filed March 1, 2021
Neither press release reporting a letter (March 2021, August 2022) names Rovi, the facility both FDA letters name.
Open the document →FDA Complete Response Letter, August 4, 2022 · page 2
During a recent inspection of the and Rovi Pharma Industrial Services S.A (FEI 3016688535) manufacturing facilities for this application, our field investigators conveyed deficiencies to the representatives of the facilities. Satisfactory resolution of these deficiencies is required before this application may be approved.Open at the source →
FDA Complete Response Letter, August 4, 2022 · page 4
Please refer to correspondence dated July 20, 2022, which addresses the proposed proprietary name, Defencath. This proposed name is unacceptable due to confusion with another product that is also under review. Therefore, the ultimate acceptability of your proposed proprietary name, Defencath, is dependent upon which application is approved first.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
The August 2022 press release does not mention the proprietary name or the letter's finding on it.
Open the document →CorMedix Form 8-K, filed August 9, 2022
has entered into an agreement with Alcami Corporation, a US based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products, which will serve as an alternative manufacturing site for DefenCath. The Company has been working with Alcami over the past several months to transfer the manufacturing process for DefenCath into an Alcami site, and CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
While I am disappointed that we will not receive FDA approval for the NDA on our PDUFA date, I am encouraged to have substantive labeling and clinical review completed by FDA and I am confident there is line of sight to FDA approval of the NDA, once either our existing CMO and API supplier obtain compliance clearance, or we are able to submit and obtain regulatory approval for manufacturing at Alcami.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
CorMedix has supported the efforts of the CMO to compile robust responses and corrective action plans to inspectional observations the CMO received during the FDA’s recent pre-approval inspection of the CMO for the DefenCath NDA. The FDA has not yet advised the CMO of the post-inspection compliance classification, but CorMedix will continue to provide any needed support in the upcoming weeks as the CMO completes implementation of all necessary corrective actions.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
August 8, 2022 CORMEDIX INC. (Exact name of registrant as specified in its charter) Delaware 001-34673 20-5894890 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 300 Connell Drive , Suite 4200 Berkeley Heights , NJ 07922 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 908 ) 517-9500 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2, below): ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Exchange Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, $0.001 par value CRMD The Nasdaq Stock Market LLC Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 8.01 Other Events On August 8, 2022, CorMedix Inc. (the “Company”) issued a press release announcing that a second Complete Response Letter was received from the U.S. Food and Drug Administration (“FDA”), stating that the New Drug Application (“NDA”) for DefenCath cannot be approved until the deficiencies conveyed to the contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of FDA.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
A second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA. There were no other deficiencies related to DefenCath cited in the CRL, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath NDA.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
Separately, the FDA conducted a recent inspection unrelated to DefenCath at the facility of the company’s heparin supplier, which culminated in the API supplier receiving a warning letter as a result of manufacturing deficiencies for a non-heparin API. CorMedix sought guidance from FDA as to whether these deficiencies would impact the timing of approval of the DefenCath NDA, and by way of the CRL, the FDA has now informed the company that satisfactory resolution of these deficiencies will be required before the DefenCath NDA may be approved. The Company’s heparin supplier has advised CorMedix that it has retained an independent CGMP consultant to expedite the implementation of corrective actions and resolve the warning letter as quickly as possible.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
The Company understands that the inspectional deficiencies at these manufacturing facilities could not be resolved prior to the PDUFA date.Open at the source →