On May 18, 2018 AstraZeneca announced the FDA approval of their new drug Lokelma, for the treatment of hyperkalemia. The full new release is reproduced below:
The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia,1 a serious condition characterized by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.2
The risk of hyperkalemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.2,3 To help prevent the recurrence of hyperkalemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.3,4
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are pleased by today’s FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalemia. The consequences of hyperkalemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.”
Lokelma is a highly-selective, oral potassium-removing agent.1 The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label trials, which showed that for patients receiving Lokelma the onset of action was at 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours from baseline.1,8 The treatment effect was maintained for up to 12 months.1,5,6,7,8
Steven Fishbane, MD, Professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York, said: “This FDA approval represents an exciting milestone, as it stands to deliver a rapid, effective and generally well-tolerated treatment option to patients suffering from hyperkalemia in the US.”
The European Commission granted marketing authorization for Lokelma in the European Union on 22 March 2018.
The risk of hyperkalemia increases significantly for patients with CKD and for those who take common medications for HF, such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalemia occurs in 23% to 47% of patients with CKD and/or HF, with an estimated 200 million and 38 million people, respectively, living with each condition worldwide. Hyperkaliemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly.
Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly-selective potassium-removing agent. It is administered orally, is odorless, tasteless and stable at room temperature. It has been studied in three double-blind, placebo-controlled trials and in two 12-month open label clinical trials in adult patients with hyperkalemia.
About AstraZeneca in Cardiovascular, Renal & Metabolism
Cardiovascular and metabolic diseases are a main therapy area and a key growth platform for AstraZeneca, which is now called Cardiovascular, Renal & Metabolism (CVRM), following the addition of Lokelma to our portfolio of medicines.
By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of these diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVRM health for millions of patients worldwide.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
Commentary: hyperkalemia is a common complication in patients with chronic kidney disease, particularly those who require treatment with renin-angiotensin aldosterone (RAAS) inhibitors. Until recently, the only available oral treatment for hyperkalemia was sodium polystyrene sulfonate (Kayexalate). In 2015 another drug, patiromer (Valtessa), was approved for this indication and provided a new treatment option. The recent approval of sodium zirconium cyclosilicate (Lokelma) provides an addition treatment choice for hyperkalemia. With the availability of oral therapies, patients should be able to take their RAAS inhibitors without the fear of hyperkalemia and without the need for frequent blood tests. It remains to be seen if these new treatments will have a favorable impact on long-term patient outcomes.
© M Loghman-Adham, MD