TMCnet News
AVEROA Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of AVA1014 for Treating Complications Associated with Chronic Kidney DiseaseGrenoble, France, 23rd April 2024 - Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, announces the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Ferric Citrate Coordination Complex (AVA1014), an oral iron-based compound for patients suffering from Chronic Kidney disease (CKD). Ferric Citrate Coordination Complex (AVA1014) was licensed from Akebia Therapeutics, Inc. (Akebia) in December 2022. Since then, Averoa has revised the clinical package and the regulatory strategy using all clinical studies and recent scientific publications to address the specific needs of the European market. The MAA submission is supported by three pivotal clinical studies performed by Akebia. The EMA will review the accepted application under the centralised marketing authorisation procedure and a decision on a potential approval is expected in 2025. This centralised procedure means that a single marketing authorisation application can be submitted to the European Union (EU), and, if approved, allows Averoa to market and make Ferric Citrate Coordination Complex (AVA1014) available to patients and healthcare professionals throughout the EU. “The submission of Averoa’s first product to the EMA is an exciting milestone as we seek to expand our portfolio of in-licenced products,” said Luc-André Granier, President and Medical Director at Averoa. “Patients with chronic kidney diseases are faced with a significant burden of disease requiring long-term treatment nd there remains a high unmet need.” *** About CKD CKD is commonly associated with two common debilitating disorders, Iron Deficiency Anaemia (IDA) and Mineral Bone Disorders (MBD). Depending on the stage of the disease, CKD can induce cardiovascular diseases. CKD can progress to end-stage kidney failure, which is fatal without dialysis or kidney transplant. About AVA1014 AVA1014 has been approved and is being commercialised in different regions: in the United States (US) under the brand name Auryxia® (ferric citrate) by Akebia Therapeutics, Inc.; in Japan as Riona® (ferric citrate hydrate) by Japan Tobacco Inc.; in Taiwan as Nephoxil® by Panion & BF Biotech Inc.; and in South Korea as Nephoxil® by Kyowa Kirin Korea Co. Ltd. About Averoa More information is available on our website www.averoa-pharma.org Contacts:
|