CorMedix hit with second CRL for antifungal treatment, citing manufacturing and API issues
Following a C-suite shuffle, a shuttering of its European operations and a CRL for its treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, CorMedix is still not impressing the FDA.
The biotech has now been given a second rejection letter, as the NDA surrounding its antifungal solution, DefenCath, cannot be approved until issues surrounding its contract manufacturing organization and the supplier of the API heparin during inspections are resolved, CorMedix said Monday afternoon.
While CorMedix has been working with its third-party manufacturer to correct any problems, it has still not been cleared to go ahead with the NDA.
Separately, the FDA also inspected the facility of the company’s heparin supplier. This led to a warning letter for the API supplier for having manufacturing deficiencies for a non-heparin API. Though the supplier has retained an independent consultant to correct the problems, they could not be resolved before the PDUFA date.
As a result of these issues, CorMedix has now sought another CMO in Alcami Corporation and is in the process of having its tech transferred over. CorMedix is also getting its supply of heparin from another alternative source as well. CorMedix now expects to send its NDA back around the first quarter of next year.
“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 a 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,” said CorMedix CEO Joe Todisco in a statement.
This is not the first time the company has faced outside manufacturing problems. Last year’s CRL also stemmed from delays from a contracted manufacturer, prompting the company to go through the resubmission process a second time.
Right after this, the company ended its European business and discontinued the distribution of Neutrolin, which is used to prevent catheter-related blood infections, devoting its full focus to DefenCath.