OxThera Receives Positive Decision From EMA on Paediatric Investigational Plan (PIP) for Treatment of Primary Hyperoxaluria With Oxalobacter Formigenes (Cision PR Newswire)

OxThera Receives Positive Decision From EMA on Paediatric Investigational Plan (PIP) for Treatment of Primary Hyperoxaluria With Oxalobacter Formigenes

UF startup OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announced that, based on a positive opinion from the Paediatric Committee (PDCO), the European Medicines Agency (EMA) has agreed to the proposed PIP for Oxalobacter formigenes in the treatment of primary hyperoxaluria.

“We are pleased to announce this important regulatory milestone. The approval of the Paediatric Investigational Plan provides us with a clear development path for Oxabact in the treatment of pediatric patients with primary hyperoxaluria,” said Matthew Gantz, CEO of OxThera.

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