USFDA17 Apr 2025, 03:31 pm
Venus Remedies' VRP-034 Granted QIDP Designation by US FDA for Treatment of Bloodstream Infections
AI Summary
Venus Remedies Limited announced that its investigational product VRP-034 has been granted Qualified Infectious Disease Product (QIDP) designation by the US FDA for the treatment of bloodstream infections caused by polymyxin B-susceptible strains in adults. The QIDP designation provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States.
Key Highlights
- VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, developed by Venus Medicine Research Centre (VMRC), the R&D division of Venus Remedies
- VRP-034 has been granted QIDP designation by the US FDA for the treatment of bloodstream infections caused by polymyxin B-susceptible strains in adults
- The QIDP designation provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States
- VRP-034 is designed to address the nephrotoxic effects associated with conventional polymyxin B therapy
- Venus Remedies has developed VRP-034 using its proprietary Renal Guard technology and kidney-on-a-chip technology