Shots:

• The approval of the Pediatric Investigational Plan (PIP) is based on PDCO’s positive opinion for Oxabact (Oxalobacter formigenes) to treat pediatric patients with primary hyperoxaluria
• Oxabact is currently evaluated in an ongoing P-III PBO controlled clinical study across sites the US and Europe- monitoring the change in plasma oxalate and estimated glomerular filtration rate (eGFR) @12 mos.- and will together with the follow-up study evaluating clinical benefits
• Oxabact is a bi-modal enteric biotherapy comprising a lyophilized formulation of Oxalobacter formigenes which is non-pathogenic- oxalate-degrading commensal bacterium and is administered orally as a coated capsule- act by promoting the secretion of oxalate from the plasma into the gut- eliminates oxalate via gut thus reducing the burden on kidneys

Click here to­ read full press release/ article | Ref: Business Wire | Image: Cision News