OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria

 OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria

OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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