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AstraZeneca : China Approves Lokelma To Treat Adult Patients With Hyperkalaemia

British drug major AstraZeneca (AZN,AZN.L) said that China has approved Lokelma for the treatment of adult patients with hyperkalaemia, elevated levels of potassium in the blood.

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.

Hyperkalaemia is characterised by high levels of potassium in the blood.The risk of hyperkalaemia increases significantly for patients with chronic kidney disease or CKD and for those who take common medications for heart failure (HF), such as RAAS inhibitors, which can increase potassium in the blood.

Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly.

Separately, AstraZeneca said that the US Food and Drug Administration has accepted a supplemental New Drug Application or sNDA and granted Priority Review for Farxiga to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type-2 diabetes.

Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2.

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

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