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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