Venus Remedies' Polymyxin B Gets US FDA QIDP Designation

The United States Food and Drug Administration (US FDA) has designated Venus Remedies Limited, a Panchkula-based pharmaceutical company that specializes in critical care injectables, as a Qualified Infectious Disease Product (QIDP) for the treatment of adult bloodstream infections brought on by strains susceptible to polymyxin B (PMB).

VRP-034, a novel supramolecular cationic (SMC) formulation of polymyxin B sulfate, was created by Venus Medicine Research Centre (VMRC), the research and development section of Venus Remedies. It was specifically created to address the nephrotoxic consequences linked to traditional polymyxin B therapy.

The Generating Antibiotic Incentives Now (GAIN) Act's QIDP designation offers VRP-034 a number of important regulatory advantages, such as priority review, fast track designation eligibility, and an extra five years of market exclusivity following approval in the US.

Venus Remedies has used its own Renal Guard technology to create the innovative polymyxin-B formulation, VRP-034. In order to investigate proven kidney injury biomarkers, such as KIM-1, cystatin C, NAG, and NGAL, in response to polymyxin-B, an antibiotic used to combat multidrug-resistant Gram-negative bacteria, the business used kidney-on-a-chip technology (based on the Organ-on-a-Chip model). These revelations had a direct impact on the development of its Renal Guard technology, which served as the basis for the new formulation VRP-034, which was created with the express purpose of reducing nephrotoxicity while maintaining therapeutic effectiveness.