FDA Approves Lokelma
FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
May 18, 2018 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
Hyperkalemia is a serious condition characterized by high levels of potassium in the blood (greater than 5.0 mEq/L). 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. Currently, patients who experience hyperkalemia while taking guideline recommended RAAS-inhibitor therapy, often have their therapy modified or discontinued.
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. The FDA approval comes on the back of Lokelma receiving authorization from the European Commission (EC) for the treatment of hyperkalemia in adult patients and it is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials.
Data from one clinical trial showed that for patients receiving Lokelma, the onset of action was at one hour, the median time to achieving normal potassium levels in the blood was 2.2 hours, and 92% of patients achieved normal potassium levels within 48 hours from baseline. Lokelma should not be used as an emergency treatment for life-threatening hyperkalemia. Lokelma was effective in lowering potassium levels in patients with CKD, HF, diabetes and those taking RAAS inhibitors. The most common adverse event was mild to moderate edema at 6% with the recommended dose of 10 g once daily (range of 4 - 16% with 5 -15 g daily).
Steven Fishbane, MD, Professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York, and lead investigator of the ZS 005 study 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 risk of hyperkalemia is associated with common comorbidities including chronic kidney disease, heart failure and diabetes, and these are the same conditions in which RAAS- inhibitors are recommended in guidelines. To help prevent the recurrence of hyperkalemia, important guideline recommended RAAS-inhibitor therapy is often modified or discontinued. Hyperkalemia may affect 40 to 50% of patients with CKD, and up to 50% of chronic heart failure (CHF) patients on RAAS inhibitors.
About Lokelma (sodium zirconium cyclosilicate) for Oral Suspension
Lokelma (formerly known as ZS-9) is an insoluble, non-absorbed sodium zirconium silicate and acts as a highly selective potassium-removing agent. It is administered orally as an odorless and tasteless powder reconstituted in water. Stability trials indicate that it is stable at room temperature. The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials, with nearly 1,800 patients that have been treated with Lokelma to date.
About AstraZeneca in Renal-Cardio
AstraZeneca’s Renal-Cardio team takes a patient-centric approach that follows the science to address the multiple risk factors associated with Renal-Cardio disease, including a key strategic focus on chronic kidney disease (CKD). By leveraging our expertise in cardiovascular disease, AstraZeneca can better understand the interplay of these conditions and CKD to advance our scientific leadership in the Renal-Cardio space. Through novel therapies and therapy combinations that target both the complications of CKD and the underlying mechanisms of CKD progression, we are building a portfolio to aggressively help prevent, treat, manage and modify this public health issue in the US and globally.
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 main 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-us.com and follow us on Twitter @AstraZenecaUS.
Posted: May 2018
- AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia - March 17, 2017
- FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia - October 18, 2016
- AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia - May 27, 2016
- ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application - July 29, 2015
- ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia - May 26, 2015