LONDON: Arix Bioscience plc, a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company Atox Bio, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for reltecimod.
The proposed indication is for the treatment of suspected organ dysfunction or failure in patients with NSTI in conjunction with surgical debridement, antibiotic therapy, and supportive care.
The Prescription Drug User Fee Act (PDUFA) date set by the FDA, which is the goal date for a decision on the NDA, is 30 September 2021.
Jonathan Tobin, Managing Director at Arix and Board Director at Atox Bio, commented: “The NDA acceptance marks an important step forward in Atox Bio’s development of reltecimod for patients with NSTI, a devastating and potentially fatal disease for which there is no approved treatment.”
Arix Bioscience plc is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting-edge advances in life sciences. www.arixbioscience.com