CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers.
The green light finally came on Wednesday for the combination treatment, which reduces the risk of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease who are receiving hemodialysis through a central venous catheter.
DefenCath is a combination of CorMedix’s antimicrobial and antifungal drug taurolidine and the anticoagulant heparin. The first-in-class catheter lock solution is the only therapy approved for the prevention of CRBSIs in any patient population.
As the FDA noted, DefenCath is now only the third drug approved under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs, which was introduced in late 2016 to facilitate development and approval of certain drugs to treat serious or life-threatening infections in certain patients with unmet needs.
“We’re looking to change the paradigm from one where infections are treated after the fact,” CorMedix CEO Joe Todisco, said during the company’s third-quarter earnings call on Tuesday. “Upwards of a third of hemodialysis patients with a catheter will get a CRBSI. Half of those infections happen the first 90 days they have a catheter. So, they happen fast, they happen frequently and they’re fatal 25% of the time. I would say this is absolutely a critical unmet need.”
DefenCath is inserted into a catheter in between uses to reduce the formation of microbial agents. It reduces the risk of bacteria from the catheter entering the bloodstream.
CorMedix expects to launch DefenCath by the end of the first quarter of next year, with appreciable revenue appearing in the second half of 2024.
It is the first approval for the 17-year-old New Jersey-based company and completes an arduous path to approval after the FDA check-marked CorMedix’s new drug application in 2020.
The first CRL came in March 2021 when the FDA cited concerns at a third-party manufacturing facility. After resubmission a year later, the FDA sent another rejection letter, identifying problems with CorMedix’s supplier of heparin.
The company has switched manufacturers, now employing Spanish CDMO Rovi. It also has replaced its previous heparin supplier, bringing in North Carolina CDMO Alcami. Both suppliers were included in the drug application, but the previous supplier had an ongoing inspection issue that had yet to be resolved by September. So CorMedix scratched it from the application, Phoebe Mounts, the company’s general counsel, said during the call.
As a qualified infectious disease product, DefenCath will gain five added years of market exclusivity.
The approval was based on testing 795 kidney failure patients undergoing dialysis and showed a 71% reduction in the risk of CRBSIs.
In 2022, in order to focus on getting DefenCath across the finish in, CorMedix restructured, halting its operations in Europe and bringing on Todisco as its new CEO.