Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application for reltecimod with a Prescription Drug User Fee Act date of 30 September 2021.
The proposed indication is for the treatment of suspected organ dysfunction or failure in patients ≥12 years of age with necrotising soft tissue infection, in conjunction with surgical debridement, antibiotic therapy, and supportive care.
