CorMedix wins US approval via rarely-used pathway for drug to reduce bloodstream infections
The FDA on Wednesday approved CorMedix’s Defencath (taurolidine and heparin) to reduce catheter-related bloodstream infections in adults with kidney failure who are receiving chronic hemodialysis through a central venous catheter. Shares of the New Jersey-based company’s stock $CRMD rose by almost 20% in afternoon trading.
Defencath is just the third drug to receive a nod via the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) from 2016. According to FDA, approvals under the LPAD pathway are based on a benefit-risk assessment “that more flexibly considered the severity, rarity, or prevalence of the infection the drug is intended to treat and the lack of alternatives available for the patient population.”
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