AVEROA Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of AVA1014 for Treating Complications Associated with Chronic Kidney Disease
April 23 2024 - 6:00AM
Grenoble, 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 and there remains a high unmet
need.”
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About CKDChronic 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 ten leading causes of death in developed countries and can be
due to multiple causes, including: high blood pressure, diabetes,
high cholesterol, kidney infections, glomerulonephritis, polycystic
kidney disease, genetic conditions, autoimmune diseases, kidney
stones, smoking, age, and use of certain medicines.
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 Akebia
Therapeutics granted to Averoa an exclusive license to develop and
commercialise AVA1014 in the European Economic Area, Turkey,
Switzerland and the United Kingdom.
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 AveroaAveroa is a
biopharmaceutical company, founded in December 2021, bringing
innovative therapeutic solutions to people with renal diseases.
Averoa’s goal is to build, advance and commercialise a strong
pipeline of products to meet significant unmet medical needs of
patients with kidney or metabolic diseases.
More information is available on our website
www.averoa-pharma.org
Contacts:
AveroaLuc-André GranierPresident et Directeur
Medical Email: info@averoa-pharma.com |
MEDiSTRAVASandi Greenwood, Sylvie
Berrebiaveroa@medistrava.com |