04 Jun Akebia Scores Another Potential Win in Kidney Disease!
Akebia Therapeutics, Inc. (NASDAQ: AKBA), a biopharmaceutical developing cutting-edge therapies for the treatment of patients with kidney diseases, announced the acceptance of the filing of its New Drug Application (NDA) for its lead product candidate, Vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, intended for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.
The Company’s lead product candidate, Vadadustat, is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, which can aid in improved red blood cell production and oxygen delivery to tissues. The candidate is based on Nobel Prize-winning science, and utilizes HIF PHIs to replicate the body’s response to lower levels of oxygen, thereby increasing the availability of HIF, a protein essential for erythropoietin synthesis and the regulation of iron metabolism.
John P. Butler, Chief Executive Officer of Akebia commented,
“The acceptance of our vadadustat NDA filing marks another important milestone for Akebia and Otsuka, as we work to bring a new oral treatment option to patients living with anemia due to CKD. We remain confident in the clarity and quality of our data, and we look forward to working with the FDA during their review of our application. In addition, we continue to collaborate with our partners to ensure we are well positioned to support a successful commercial launch of vadadustat, upon FDA approval.”
In December 2016, the Company had entered into a collaboration and license agreement with Otsuka Pharmaceuticals for development of vadadustat in the U.S, which provided the capital needed for funding the development and potential commercialization of the candidate. Akebia received an upfront payment of $265 million, in addition to being eligible for developmental and commercial milestones payments which could exceed $1 billion.
The Companies submitted a New Drug Application (NDA) to the Food and Drug Administration. (FDA) in the U.S in March 2021. Akebia and Otsuka revised their collaboration and license Agreement in 2017 to explore the application of vadadustat in other areas. The companies have equal development rights in Europe, Canada, Australia, Russia and China and are preparing to file a Marketing Authorization Application for vadadustat to the European Medicines Agency in 2021.
Akebia Therapeutics, Inc. (NASDAQ: AKBA)
Market Cap: $ 533.18M; Current Share Price: 3.33 USD
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Anemia is a condition in which the body produces lower-than-normal hemoglobin or red blood cells, disrupting the flow of oxygen to important tissues and organs in the body such as heart and brain. People who suffer from chronic kidney disease (CKD) often develop anemia of renal disease as the disease progresses and kidneys lose their ability to filter blood effectively.
According to an estimate by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) over 37 million adults in the U.S suffer from CKD and 1 out of 7 patients with kidney disease have anemia. The disease is more pronounced for people also suffering from diabetes as they tend to develop a more severe form of anemia. This can also lead to heart issues and strokes in the long run as the heart may not be receiving sufficient oxygen for optimal functioning.
Anemia manifests in the form of fatigue, pale skin, shortness of breath, chest pain, dizziness, irregular heartbeat among others. The Current treatment options consist of a combination of prescribing iron supplements, vitamins, IV or subcutaneous erythropoiesis-stimulating agent (ESA) that stimulate the bone marrow to produce more red blood cells or blood transfusion.
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The Company is focused on creating novel therapeutics for addressing the unmet needs in kidney diseases. Akebia markets AURYXIA (ferric citrate) in the U.S, which is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis as well as for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. The Company’s core focus remains on kidney diseases and is working on adding to its portfolio through internal research and development, in-licenses, strategic collaborations and acquisitions.
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Akebia has commercial products approved and marketed in the U.S, Japan and Taiwan.
The Company’s science is based on oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) that imitate the body’s response to inadequate levels of oxygen. In case of lack of sufficient oxygen, the body naturally increases HIF, a protein responsible for erythropoietin synthesis and regulation of iron metabolism. hypoxia-inducible factor prolyl hydroxylase (HIF-PH) can result in improved red blood cell production and oxygen delivery.
The Company has evaluated the candidate in two pivotal phase 3 trials namely PRO2TECT (non-dialysis) and INNO2VATE (dialysis).
Akebia has multiple strategic collaborations and partnerships with companies such as Mitsubishi Tanabe Pharma Corporation, Vifor Pharma, Janssen, Panion & BF Biotech and Japan Tobacco. The Mitsubishi Tanabe Pharma Corporation (MTPC) submitted a Japanese New Drug Application (JNDA) in June 2019, and was granted an approval on June 29, 2020, and is currently marketed in Japan as VafseoTM, intended for the treatment of anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
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References
https://www.otsuka-us.com/discover/articles-985
https://www.niddk.nih.gov/health-information/kidney-disease/anemia#CKD
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