MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil
Time:2023-09-21 / View:339 times
MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation 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 for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis.
The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII–Generating Antibiotic Incentives Now (GAIN) Act, to encourage development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. Once a new drug is qualified for QIDP, it will be granted two incentive policies: an additional five years of market exclusivity after launch, and a priority review during the review phase.
Dr. Zhengyu Yuan, chairman and CEO of MicuRx Pharmaceutical, 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.” Contezolid Tablets and MRX-4 are oxazolidinone antibiotics independently developed by MicuRx Pharmaceutical, mainly focusing on drug-resistant Gram positive bacterial infections. At present, the global phase III clinical trial of MRX-4 sequential contezolid for injection in the treatment of diabetes foot infection is in progress. As early as 2018, the indications for acute bacterial skin and skin structural infections (ABSSSI) with contezolid tablets and MRX-4 were awarded QIDP qualification and fast track. The qualification of fast track and QIDP won this time will bring more convenience for the approval of contezolid tablets and MRX-4 in the United States, and bring more drug choices to the majority of patients with diabetes foot infection as soon as possible.