China’s NMPA Greenlights LOKELMA Label Update for Haemodialysis, Hyperkalaemia Patients
Several patients with chronic kidney disease (CKD) suffer from hyperkalaemia, a condition characterized by high levels (>5mmol/L) of potassium in the blood. Approximately 700 million people are currently living with CKD, and among them, 23-47% experience hyperkalaemia. Although CKD patients more or less undergo haemodialysis, they still struggle with the flux in their potassium levels.
Around 25% of 300,000 in Europe and 500,000 in the US still have serum potassium greater than 5.5mmol/L even after receiving adequate haemodialysis. That number is even more severe in China, with “more than 550,000 patients with chronic kidney disease on haemodialysis are at risk of developing hyperkalemia,” according to Mene Pangalos, Executive Vice President, BioPHarmaceuticals R&D.
Updated Label for LOKELMA
Fortunately, many countries, including the US, EU, Canada, Hong Kong, Russia, and Japan, approved an updated label for LOKELMA in succession because the Phase IIIb DIALIZE trial demonstrated LOKELMA’s effectiveness in lowering potassium levels in CKD patients. The label update includes a dosing regimen for patients on chronic haemodialysis with a starting dose of 5g once daily on non-dialysis days and, in the case of patients with serum potassium greater than 6.5 mmol/L, a starting dose of 10g once daily on non-dialysis days.
On November 24th, China’s National Medical Products Administration (NMPA) finally approved LOKELMA’s label update. “This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia. LOKELMA will offer the opportunity for patients and physicians to achieve long-term disease control and potentially reduce the risk of acute episodes, which can have serious, even life-threatening consequences,” said Pangalos.
LOKELMA (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate formulated as a powder for oral administration to remove potassium effectively. However, it should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. It has been studied in three double-blinded, placebo-controlled trials and in one 12-month open-label clinical trial in patients with hyperkalemia.
Phase IIIb DIALIZE Trial
DIALIZE is the first of the three randomized, placebo-controlled trials to assess LOKELMA as a potassium binder in patients on stable haemodialysis. The Phase IIb trial enrolled 196 patients on haemodialysis with hyperkalemia, who were randomized to receive LOKELMA or placebo once daily on non-dialysis days for a treatment period of eight weeks. Within the duration of eight weeks, one four-week dose adjustment was implemented; the dose initially began at 5g and titrated weekly in 5g increments up to a maximum of 15g. The full results of the DIALIZE trial were published in the Journal of the American Society of Nephrology in September 2019.
The results showed that compared to placebo, LOKELMA demonstrated a significant, statistical improvement in patients by maintaining serum potassium at 4-5 mmol/L during at least three of four haemodialysis sessions after the long interdialytic interval of the last four weeks of treatment and requiring no urgent rescue therapy. In 41.2% of participants, LOKELMA yielded obvious decreases in serum potassium concentration, compared to 1% with placebo. In addition, 2.1% of enrollees treated with LOKELMA needed rescue therapy to reduce serum potassium for severe hyperkalemia during the treatment period compared with 5.1% of the placebo arm.
The trial cleared safety concerns, as the safety profile of LOKELMA was consistent with that seen in previous trials. The common adverse reaction was mild to moderate edema.
By Judy Ya-Hsuan Lin
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