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Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Shots:

  • The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK’s MAA will be filed via MHRA’s IRP, with decision anticipated in the coming mos.
  • MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials conducted by Akebia Therapeutics
  • Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its dossier with a re-engineered clinical package to support dual indications for EU pts. Averoa is currently seeking commercial partners for EU launch & distribution

Ref: Globenewswire | Image: Averoa 

Related News:- Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3G and Primary IC-MPGN

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