US FDA approves CorMedix's antimicrobial drug (updated)

CorMedix

15/11/2023 15:23

(Adds details and background in paragraphs 2 to 4)
       Nov 15 (Reuters) - The U.S. Food and Drug Administration
(FDA) has approved CorMedix's  CRMD.O  antimicrobial drug,
DefenCath, that aims to reduce catheter-related bloodstream
infections (CRBSIs) in patients with kidney disease, the
regulator said on Wednesday.
    DefenCath will become the company's first commercial drug
following the FDA decision, marking a win for CorMedix, which
has been trying to bring it to market since 2020.
    The drug is inserted into a catheter before use, which helps
prevent formation of microbial communities and  reduces the
presence of bacteria in the bloodstream originating from the
intravenous tube.
    DefenCath was evaluated in patients undergoing dialysis with
catheters inserted into a large central vein.

 (Reporting by Christy Santhosh in Bengaluru; Editing by
Shailesh Kuber)
 ((Christy.Santhosh@thomsonreuters.com;))