OxThera's Oxabact PIP gets thumbs up from EMA

Privately-held Swedish biotech OxThera today announced that, based on a positive opinion from the Pediatric Committee (PDCO), the European Medicines Agency has agreed to the proposed pediatric investigation plan (PIP) for Oxalobacter formigenes in the treatment of primary hyperoxaluria (PH).

"We are pleased to announce this important regulatory milestone. The approval of the Pediatric Investigational Plan provides us with a clear development path for Oxabact [oxalobacter formigenes] in the treatment of pediatric patients with primary hyperoxaluria," said Matthew Gantz, chief executive of OxThera.

Primary hyperoxaluria is a rare autosomal recessive disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine. High levels of oxalate cause kidney damage, primarily driven by crystallization of oxalate in tissues and in the kidney and can cause kidney failure and premature death.