US FDA approves CorMedix’s drug for bloodstream infections

Nov 15 (Reuters) – U.S. health regulators on Wednesday approved CorMedix’s (CRMD.O) antibiotic to reduce catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, marking the company’s first It is now possible to sell commercially available products.

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

The New Jersey-based company’s stock had risen 32% by midday, helped by a lower-than-expected third-quarter loss reported earlier in the day.

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

In 2021, the FDA cited doubts about DefenCath’s third-party manufacturing facility, and a year later raised concerns about its heparin suppliers.

in advance of drug approvalCormedix said it has changed suppliers for its heparin and that the FDA has inspected its current manufacturing facility and is satisfied with it.

Brokerage RBC said Cormedix’s recent steps including hiring and preparation of drug inventory could help DefenCath’s successful launch.

RBC added that the company does not expect significant revenue contribution from the drug until the second half of 2024.

The drug was tested in 795 patients undergoing dialysis and was shown to reduce the risk of developing a CRBSI by 71% in patients with kidney failure.

Defencath acts as a locking solution that is inserted into the central venous catheter between uses, reducing the formation of microbial communities and reducing the risk of bacteria in the bloodstream originating from IV tubing.

CorMedix is ​​also developing catheter locking solutions for use in oncology treatment and parenteral nutrition.

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