OxThera Receives Rare Pediatric Disease Designation from U.S. FDA for Oxabact Treatment of Primary Hyperoxaluria
Stockholm – June 26 2020. OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Rare Pediatric Disease Designation for Oxabact OC5. The FDA stated, that based on information provided by OxThera, there is sufficient documentation to demonstrate that nephrocalcinosis, nephrolithiasis, growth failure, and oxalate retinopathy are serious manifestations of PH that primarily affect children. Therefore, Oxabact is eligible for and has been