China NMPA Approves Label Updation For AstraZenecas Lokelma For Patients With Hyperkalaemia On Chronic Haemodialysis

The National Medical Products Administration (NMPA) has approved a dosing label update in China for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on chronic haemodialysis.The approval by the NMPA was based on data from the phase IIIb DIALIZE trial, the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.Lokelma was approved for the treatment of adult patients with hyperkalaemia in China by the NMPA in December 2019.Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said, “In China, more than 550,000 patients with chronic kidney disease on haemodialysis are at risk of developing hyperkalaemia, which can in turn lead to arrythmias and cardiac arrest. This label update provides guidance to manage hyperkalaemia in this high-risk patient population, potentially enabling improved long-term treatment and overall kidney care.”In DIALIZE, 41% of patients receiving Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. This compared with 1% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement (p<0.001). The safety profile of Lokelma observed in DIALIZE was consistent with previous trials.Lokelma is a highly selective, oral potassium-removing agent currently approved in a number of markets across the globe including the US, China, EU and Japan for the treatment of hyperkalaemia.Earlier this year, the US Food and Drug Administration (US FDA) and the European Commission (EC) approved label updates in the US and EU, respectively, to include a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on chronic haemodialysis.Hyperkalaemia is characterised by high levels of potassium in the blood, generally defined as greater than 5mmol/L. Many people living with chronic kidney disease (CKD) have hyperkalaemia despite being on haemodialysis and often experience fluctuations in their potassium levels. In Europe, approximately 300,000 patients with end-stage renal disease are undergoing haemodialysis, and more than 500,000 patients in the US are living with dialysis-dependent end-stage renal disease. Despite adequate haemodialysis, up to 25% of patients have serum potassium >5.5 mmol/L. Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias, which can lead to cardiac arrest. Worldwide, there are an estimated 700 million and 64 million people living with CKD and HF respectively with hyperkalaemia occurring in 23 to 47% of patients with advanced CKD (stage 3-4) and/or HF.DIALIZE is the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The phase IIIb, multicentre, double-blinded trial investigated the efficacy and safety of Lokelma versus placebo in 196 patients on haemodialysis with hyperkalaemia. Patients were randomised 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 (starting at 5g and titrated weekly in 5g increments up to a maximum of 15g) and a four-week evaluation phase on stable dose.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, is odourless, tasteless and stable at room temperature. It has been studied in three double-blinded, placebo-controlled trials and in one 12-month open label clinical trial in patients with hyperkalaemia

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!