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Akebia Therapeutics Announces Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Adopted A Positive Opinion Recommending The European Commission To Approve Xoanacyl For Treatment Of Concomitant Elevated Serum Phosphorous And Iron Deficiency In Adult Patients With Chronic Kidney Disease

Benzinga·04/03/2025 12:15:19
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Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL® (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).

Averoa, a renal-focused biopharmaceutical company, licensed the rights to develop and commercialize ferric citrate from Akebia in the European Economic Area and certain countries in Europe and the Middle East. Averoa recently announced the positive opinion from CHMP here: https://averoa-pharma.org/wp-content/uploads/2025/04/20250402-AVA1014-Positive-opinion-EN-VF-2.04.2025.pdf.

"We congratulate our partner Averoa on a positive step toward securing EMA approval for XOANACYL, and we will continue to support their efforts to deliver a treatment for complications of kidney disease to patients in Europe," said John P. Butler, Chief Executive Officer of Akebia.

The EC will review the CHMP recommendation, and a final decision is expected in approximately two months.