Wednesday, April 24, 2024
Averoa, a biopharmaceutical company focused on innovative therapeutic solutions for renal diseases, has announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Ferric Citrate Coordination Complex (AVA1014), an oral iron-based compound intended 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 carefully revised the clinical package and regulatory strategy using all available clinical studies and recent scientific publications to tailor the submission to meet the specific needs of the European market. The MAA submission is supported by three pivotal clinical studies conducted by Akebia.
The EMA will review the application under the centralized marketing authorization procedure, with a decision expected in 2025. This procedure allows for a single marketing authorization application to be submitted to the European Union (EU), potentially enabling Averoa to market Ferric Citrate Coordination Complex (AVA1014) throughout the EU if approved.
"The submission of our first product to the EMA is a significant milestone as we aim to expand our portfolio of in-licensed products," said Luc-André Granier, President and Medical Director at Averoa. "Patients with chronic kidney diseases face a substantial burden of disease requiring long-term treatment, and there remains a high unmet need."
Chronic Kidney Disease (CKD) refers to the gradual loss of kidney function and is a major public health concern, affecting millions of people with an estimated prevalence ranging from 3% to 17% in Europe. CKD can result from various causes, including high blood pressure, diabetes, kidney infections, and genetic conditions, among others.
CKD is often associated with Iron Deficiency Anemia (IDA) and Mineral Bone Disorders (MBD), and depending on the disease stage, it can lead to cardiovascular diseases and progress to end-stage kidney failure, which is fatal without intervention such as dialysis or kidney transplant.
AVA1014, licensed from Akebia Therapeutics, is already approved and marketed under different brand names in various regions, including the United States (as Auryxia®), Japan (as Riona®), Taiwan (as Nephoxil®), and South Korea (as Nephoxil®).
Source: globenewswire.com
