Venus Remedies said its investigational antibiotic, VRP-034, received Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration (USFDA) for treating bloodstream infections.
The QIDP status, granted by USFDA, makes VRP-034 eligible for regulatory benefits including priority FDA review, potential fast-track designation, and an additional five years of market exclusivity in the U.S. upon approval.
Venus Remedies shares gained 8.09% to close Rs 336.80 on BSE.
The designation, announced Thursday, is for VRP-034's potential use against infections caused by specific polymyxin B-susceptible strains in adults.
VRP-034 is a novel formulation of the antibiotic polymyxin B sulphate, developed by Venus Medicine Research Centre (VMRC), the company's R&D division. It aims to reduce the severe kidney toxicity (nephrotoxicity) often associated with conventional polymyxin B treatments, which affects up to 60% of patients.
Polymyxins are considered last-resort antibiotics against multi-drug resistant Gram-negative bacteria, but their use is limited by kidney damage risk. Venus Remedies developed VRP-034 using its proprietary Renal Guard technology to minimize this toxicity while maintaining efficacy. Preclinical studies showed VRP-034 resulted in up to a 70% reduction in nephrotoxicity compared to currently marketed polymyxin B.
“Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance,” said Saransh Chaudhary, CEO of Venus Medicine Research Centre. “QIDP recognition for VRP-034 underscores the urgent global need for safer polymyxin-based therapies and validates the strength of our scientific approach”.
Venus Remedies based in Panchkula, Haryana, specializes in critical care injectables and is a significant player in combating antimicrobial resistance (AMR).
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