Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa
Akebia Therapeutics (AKBA) announced that the European Medicines Agency's CHMP has adopted a positive opinion recommending approval for XOANACYL® (Ferric Citrate as Coordination Complex). The drug is intended for treating elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
The treatment rights in the European Economic Area and certain countries in Europe and the Middle East are licensed to Averoa, a renal-focused biopharmaceutical company. The European Commission is expected to make a final decision on XOANACYL's approval in approximately two months.
Akebia Therapeutics (AKBA) ha annunciato che il CHMP dell'Agenzia Europea dei Medicinali ha adottato un parere positivo che raccomanda l'approvazione per XOANACYL® (Citrato Ferroso come Complesso di Coordinazione). Il farmaco è destinato al trattamento dell'elevato fosforo sierico e della carenza di ferro nei pazienti adulti con malattia renale cronica (MRC).
I diritti di trattamento nell'Area Economica Europea e in alcuni paesi in Europa e in Medio Oriente sono concessi in licenza a Averoa, una società biofarmaceutica focalizzata sui reni. Si prevede che la Commissione Europea prenda una decisione finale sull'approvazione di XOANACYL entro circa due mesi.
Akebia Therapeutics (AKBA) anunció que el CHMP de la Agencia Europea de Medicamentos ha adoptado un dictamen positivo recomendando la aprobación de XOANACYL® (Citrato Férrico como Complejo de Coordinación). El medicamento está destinado al tratamiento de niveles elevados de fósforo en suero y deficiencia de hierro en pacientes adultos con enfermedad renal crónica (ERC).
Los derechos de tratamiento en el Área Económica Europea y en ciertos países de Europa y Oriente Medio están licenciados a Averoa, una empresa biofarmacéutica centrada en los riñones. Se espera que la Comisión Europea tome una decisión final sobre la aprobación de XOANACYL en aproximadamente dos meses.
Akebia Therapeutics (AKBA)는 유럽 의약품청(CHMP)이 XOANACYL® (철 시트레이트 조정 복합체)에 대한 승인을 권장하는 긍정적인 의견을 채택했다고 발표했습니다. 이 약물은 만성 신장 질환(CKD)을 앓고 있는 성인 환자의 혈청 인산염 상승 및 철 결핍 치료를 위해 사용됩니다.
유럽 경제 지역 및 유럽과 중동의 일부 국가에서 치료 권리는 신장 중심의 생명공학 회사인 Averoa에 라이센스가 부여되었습니다. 유럽 연합 집행위원회는 약 두 달 후 XOANACYL의 승인에 대한 최종 결정을 내릴 것으로 예상됩니다.
Akebia Therapeutics (AKBA) a annoncé que le CHMP de l'Agence européenne des médicaments a adopté un avis positif recommandant l'approbation de XOANACYL® (Citrate ferrique comme complexe de coordination). Ce médicament est destiné au traitement de l'élévation du phosphore sérique et de la carence en fer chez les patients adultes atteints de maladie rénale chronique (MRC).
Les droits de traitement dans l'Espace économique européen et dans certains pays d'Europe et du Moyen-Orient sont concédés sous licence à Averoa, une société biopharmaceutique axée sur les reins. La Commission européenne devrait prendre une décision finale sur l'approbation de XOANACYL dans environ deux mois.
Akebia Therapeutics (AKBA) gab bekannt, dass das CHMP der Europäischen Arzneimittel-Agentur eine positive Stellungnahme zur Genehmigung von XOANACYL® (Eisen(III)-citrat als Koordinationskomplex) angenommen hat. Das Medikament ist zur Behandlung von erhöhtem Serumphosphor und Eisenmangel bei erwachsenen Patienten mit chronischer Nierenerkrankung (CKD) vorgesehen.
Die Behandlungsrechte im Europäischen Wirtschaftsraum und in bestimmten Ländern Europas und des Nahen Ostens sind an Averoa, ein biopharmazeutisches Unternehmen mit Schwerpunkt auf Nieren, lizenziert. Die Europäische Kommission wird voraussichtlich in etwa zwei Monaten eine endgültige Entscheidung über die Genehmigung von XOANACYL treffen.
- EMA's CHMP positive opinion increases likelihood of European market approval
- Potential revenue stream from European market through licensing agreement with Averoa
- Final EC approval still pending and not guaranteed
- Revenue potential by licensing arrangement rather than direct commercialization
CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) -- 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.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s statements regarding Averoa’s ability to secure EMA approval for XOANACYL; Akebia’s plans to support efforts to deliver a treatment for complications of kidney disease to patients in Europe; and Akebia’s expectations on the timing of a final decision from the EC. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: decisions made by health authorities, such as the FDA and the EMA, with respect to regulatory filings and other interactions; the results of preclinical and clinical research; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form 10-K for the year ended December 31, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Akebia Therapeutics® is a registered trademark of Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
FAQ
What is the significance of CHMP's positive opinion for XOANACYL (AKBA)?
When is the European Commission expected to make a final decision on XOANACYL (AKBA)?
What territories are covered by Averoa's license for XOANACYL from AKBA?
What specific conditions will XOANACYL treat for CKD patients (AKBA)?
