Venus Remedies Receives QIDP Designation for VRP-034
Mumbai: Venus Remedies Limited, a leading pharmaceutical company specializing in critical care injectables, has received Qualified Infectious Disease Product (QIDP) designation from the US FDA for its investigational product VRP-034. This novel formulation is designed to treat bloodstream infections caused by polymyxin B-susceptible strains in adults.
VRP-034 is a supramolecular cationic formulation of polymyxin B sulphate developed to mitigate nephrotoxic effects associated with conventional polymyxin B therapy. Preclinical findings show up to 70% reduction in nephrotoxicity compared to marketed polymyxin B. The formulation has also demonstrated robust efficacy against resistant pathogens in both in vitro and animal models.
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. This recognition underscores the urgent global need for safer polymyxin-based therapies and validates Venus Remedies’ scientific approach.
The QIDP designation strengthens Venus Remedies’ commitment to innovation in combating antimicrobial resistance and addressing unmet needs in infectious disease therapy. With this recognition, Venus Remedies is poised to make a significant impact in the fight against infectious diseases.
