US FDA approves CorMedix's drug for bloodstream infections

[November 16, 2023]  By Christy Santhosh

(Reuters) -The U.S. health regulator on Wednesday approved CorMedix's antimicrobial drug for reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, allowing the company to launch its first commercial product.

The company plans to ready the drug for commercialization by end of the first quarter of 2024, CorMedix CEO Joe Todisco told Reuters.

Shares of the New Jersey-based company rose 32% by mid-day, helped also by a smaller-than-expected loss for the third quarter reported earlier in the day.

DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns.

In 2021, the FDA cited doubts about the third-party manufacturing facility for DefenCath and a year later, raised concerns related to the supplier of heparin.

Ahead of the drug approval, CorMedix said it had changed its heparin supplier and the FDA had inspected its current manufacturing facility and was comfortable with it.

Brokerage RBC said that CorMedix's steps, such as recent hirings and having a ready inventory of the drug, could help with a successful launch for DefenCath.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

RBC added that the company does not see any meaningful revenue contributions from the drug until the second half of 2024.

The drug was tested in a pool of 795 patients undergoing dialysis, where it showed a 71% reduction in the risk of occurrence of CRBSIs in kidney failure patients.

Defencath works as a lock solution that is inserted into a central venous catheter in between uses to help reduce formation of microbial communities and helps reduce the risk of bacteria in the bloodstream originating from the intravenous tube.

CorMedix also has catheter lock solutions in development for use in oncology treatments and intravenous feeding.

(Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)

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