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The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025
In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…
Shots:
The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP
Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts
Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…
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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…

