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Label update is based on data from Phase IIIb DIALIZE trial
Today, the US Food and Drug Administration (FDA) approved a label update in the US for AstraZeneca’s LOKELMA® (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis.
The approval by the US FDA was based on positive results from the Phase IIIb DIALIZE trial, the first ever randomized, placebo-controlled trial to evaluate a potassium binder in patients on stable hemodialysis. The DIALIZE trial showed that a significantly higher proportion of patients in the LOKELMA group (41.2%) met the primary endpoint and were classified as responders (maintained serum potassium 4-5 mmol/L during at least three out of four hemodialysis sessions after the long interdialytic interval [LIDI] of the last four weeks of treatment and did not require urgent rescue therapy) compared to patients in the placebo group (1.0%), making it a statistically significant (P<0.001) and clinically meaningful improvement. Rescue therapy was defined as any urgent therapeutic intervention considered necessary to reduce serum potassium for severe hyperkalemia (serum potassium >6.0 mmol/L). The safety profile of LOKELMA observed in DIALIZE was consistent with previous trials.
LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. This is the first label update for LOKELMA in the US following its FDA approval in 2018 to treat adults with hyperkalemia. The label update now includes a dosing regimen for patients on chronic hemodialysis with a starting dose of 5 g once daily on non-dialysis days and a starting dose of 10 g once daily on non-dialysis days in patients with serum potassium greater than 6.5 mmol/L.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “More than 500,000 patients in the US are living with dialysis-dependent end-stage renal disease and could be at risk for dangerously high levels of potassium. With this FDA approved update, the LOKELMA label now includes important dosing guidance for treating hyperkalemia in patients on hemodialysis.”
LOKELMA is currently approved in the US, EU, Canada, Hong Kong, China, Russia and Japan for the treatment of patients with hyperkalemia. LOKELMA recently received a positive opinion from The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on a dosing and administration label update to include patients with hyperkalemia on stable hemodialysis. A final decision is expected from the European Commission in the near-future.
IMPORTANT SAFETY INFORMATION FOR LOKELMA® 5 g and 10 g (sodium zirconium cyclosilicate)
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: The most common adverse reaction in non-dialysis patients with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of non-dialysis patients treated with 5 g, 10 g, and 15 g of LOKELMA once daily, respectively vs 2.4% of non-dialysis patients receiving placebo.
DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.
INDICATION AND LIMITATION OF USE
LOKELMA is indicated for the treatment of hyperkalemia in adults.
LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
DOSING
PLEASE READ FULL PRESCRIBING INFORMATION.
Hyperkalemia
Hyperkalemia is characterized by high levels of potassium in the blood, generally classified as greater than 5 mmol/l. Many people living with chronic kidney disease (CKD) have hyperkalemia despite being on hemodialysis and often experience fluctuations in their potassium levels. Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias which can lead to cardiac arrest. Hyperkalemia occurs in 23% to 47% of patients with CKD and/or heart failure with an estimated 700 million and 64 million people respectively, living with each condition worldwide.
DIALIZE
DIALIZE is the first ever randomized, placebo-controlled trial to evaluate a potassium binder in patients on stable hemodialysis. The Phase IIIb, multicenter, double-blinded trial investigated the efficacy of LOKELMA versus placebo in 196 patients on hemodialysis with hyperkalemia. Patients were randomized to receive LOKELMA or placebo once daily on non-dialysis days for a treatment period of eight weeks. This included a four-week dose adjustment phase and a four-week evaluation phase on stable dose.
The full results of the DIALIZE trial were published in September 2019 in the Journal of the American Society of Nephrology.
LOKELMA
LOKELMA® (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally as a suspension, is odorless, tasteless and stable at room temperature. It has been studied in three double-blinded, placebo-controlled trials, in one 11-month open label clinical trial and in one 12-month open label clinical trial in patients with hyperkalemia.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys 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. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
About AstraZeneca
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. 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.
US-38712 Last Updated 4/20
View source version on businesswire.com: https://www.businesswire.com/news/home/20200427005183/en/
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