Europe’s Committee for Medicinal Products for Human Use (CMPH) has recommended approving AstraZeneca’s Lokelma for the treatment of hyperkalemia (high levels of potassium in the blood), a condition common in patients with chronic kidney disease,
The CMPH — a unit of the European Medicines Agency — based its ruling on the positive results from three double-blind placebo-controlled clinical trials (NCT02107092, NCT01493024, NCT01737697), and one ongoing 12-month open-label trial (NCT02163499) in adults with hyperkalemia, AstraZeneca announced. In total, these clinical trials represent more than 1,600 patients treated to date with Lokelma.
Results from a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial (HARMONIZE, NCT02088073) conducted in outpatients with hyperkalemia recruited from 44 sites in the United States, Australia and South Africa showed that treatment with Lokelma was able to normalize potassium levels in blood serum within 48 hours. Lokelma continued working for up to 28 days of treatment.
In another study, treatment with Lokelma also normalized potassium levels in blood serum within 48 hours, with most patients maintaining their normalized blood serum potassium levels during 12 days of maintenance therapy
Overall, in these trials, Lokelma shows ability to lower serum potassium levels. According to a CMPH press release, the most common side effects caused by Lokelma are hypokalemia (low levels of potassium in the blood serum) and oedema (swollen tissue).
The European Commission will now review CMPH’s opinion and issue a final decision on authorization of the drug.
Hyperkalemia is the result of the kidneys’ inability to excrete potassium, the impairment of the mechanisms that transport potassium into cells, or a combination of both. The causes of hyperkalemia vary from patient to patient, but the most common include diabetes, heart failure, hypertension and chronic kidney disease.
Lokelma (also known as ZS-9, sodium zirconium cyclosilicate) will be available as 5-gram and 10-gram powder for oral suspension. Sodium zirconium cyclosilicate, the active ingredient in Lokelma, selectively binds potassium throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen. This lowers serum potassium levels by drawing potassium into the GI tract and increasing fecal potassium excretion to resolve hyperkalemia.
Lokelma is also under regulatory review in Australia and by the U.S. Food and Drug Administration, with final decisions expected in the first half of 2017.