China Approves AstraZenecas Lokelma To Treat Hyperkalaemia
AstraZenecas Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with hyperkalaemia (elevated levels of potassium in the blood).
The approval by the National Medical Products Administration (NMPA) was based on positive results from the extensive Lokelma 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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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.”
Lokelma is approved in the US, the EU and Canada for the treatment of hyperkalaemia. It is undergoing separate regulatory review in Japan, with a decision expected in the first half of 2020.