Lokelma for treating hyperkalaemia in ChinaMarch 6, 2020
The approval by the National Medical Products Administration (NMPA) was based on positive results from the extensive clinical trial programme and a pharmacodynamic study in China which showed that patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium in the blood.
In 2019, the NMPA included Lokelma on the Accelerated Approval list of “Overseas New Drugs in Clinical Urgent Needs for China”, recognising the significant unmet need for effective medicines treating hyperkalaemia.
The clinical trials programme includes three double-blinded, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months. These trials showed that for patients receiving Lokelma, the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline.
Lokelma also demonstrated a rapid reduction of potassium in the blood as early as one hour with one dose and a sustained treatment effect for up to one year.