is an oral iron-based compound that binds phosphorus. Its efficacy was clinically demonstrated for both iron deficiency anemia and control of serum phosphorus levels in adult patients with chronic kidney disease.
Chronic Kidney disease (CKD) describes the gradual loss of kidney function. It is a major public health problem resulting in an important burden for patients and healthcare systems. It affects millions of people with an estimated prevalence ranging from 3 to 17% in Europe. It is one of the 10 leading causes of death in developed countries.
CKD can be due to multiple causes: High blood pressure, diabetes, high cholesterol, kidney infections, glomerulonephritis, polycystic kidney disease, genetic conditions, autoimmune diseases, kidney stones, smoking, age, use of certain medicines etc.
CKD is commonly associated with 2 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, fatal without dialysis or kidney transplant
CKD bears a substantial burden of comorbidities : - Polypharmacy is real and frequent - Suboptimal management of anemia by current therapies - Delaying the entry to dialysis or need for transplantation is a key challenge
AVA1014 is an oral compound with a dual mechanism of action that provides iron on one hand and binds phosphorus on the other hand. Its efficacy was clinically demonstrated for both iron deficiency anaemia in adult patients and control of serum phosphorus levels in adult patients with chronic kidney disease.
AVA1014 has been licensed from AKEBIA and is already registered and marketed in US under the Brand Name Auryxia® and in Japan under the Brand Name Riona®.
AVA1014 adresses 2 common debilitating disorders, i.e. anemia and mineral bone disorders that induce cardiovascular consequences and can progress to end-stage kidney failure, fatal without dialysis or kidney transplant.
Based on existing clinical and safety studies, AVEROA will apply for a marketing authorization according to the European centralized procedure.
submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of AVA1014 for Treating Complications Associated with Chronic Kidney Disease.
