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FDA designates Neutrolin as QIDP
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The FDA has designated a novel formulation as a qualified infectious disease product, for the prevention of catheter-related bloodstream infections for oncology, hemodialysis and ICU patients.
The formulation (Neutrolin, CorMedix) contains taurolidine, citrate and heparin 1,000 u/mL, and also is a preventive agent for thrombosis and biofilm, according to a company press release. The formulation also received fast track designation in early January.
QIDP designation makes Neutrolin eligible for incentives provided under the Generating Antibiotics Incentives Now (GAIN) Act, including priority FDA review, fast-track eligibility and 5-year patent extension if FDA-approved. Agents can receive QIDP designation if they are meant to treat serious or life-threatening illnesses caused by certain pathogens determined by the FDA. Neutrolin has demonstrated antimicrobial activity against a number of the qualified pathogens.
The drug has the CE mark of approval for use in the European Union. It also was recently approved to enter a phase 3 trial program in the United States.
“CorMedix is delighted that the FDA has given Neutrolin a QIDP designation, further affirming the importance of addressing the serious medical need related to catheter infections,” Randy Milby, CorMedix CEO, said in the press release. “The QIDP designation, combined with the recently achieved fast track designation, will strongly support our goal to bring Neutrolin to the US market as fast as possible.”