Therapy Areas: Infectious Diseases
MicuRx Pharmaceuticals' Contezolid and Contezolid acefosamil receive Fast Track Designation and US FDA QIDP
25 September 2023 -

MicuRx Pharmaceuticals, Inc., a US-based biopharmaceutical company, announced on Friday that it has received Qualified Infectious Disease Product (QIDP) and Fast Track Designation from the US Food and Drug Administration (FDA) under the Generating Antibiotic Incentives Now (GAIN) Act, for contezolid (MRX-I) tablet and contezolid acefosamil (MRX-4) tablet and intravenous, as novel new oxazolidinone antibiotics intended for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis.

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI. QIDP designation provides both products with a five-year extension of data exclusivity provisions and eligibility for Priority Review of its New Drug Application (NDA) for DFI once submitted. Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Dr Zhengyu Yuan, at MicuRx chief executive officer, said, 'We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection.'