AstraZeneca gets FDA green light for hyperkalaemia drug

AstraZeneca received US regulatory approval for its Lokelma treatment for high potassium levels in the blood and, separately, submitted a new drug application in Japan for a diabetes treatment.

The US Food & Drug Administration approved Lokelma, which is an insoluble, non-absorbed sodium zirconium silicate powder that acts as a highly-selective potassium-removing agent, for the treatment of adults with hyperkalaemia. European regulators gave their approval in March.

Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly. Potassium levels can rise significantly for patients with chronic kidney disease and for those who take common medications for heart failure, such as renin-angiotensin-aldosterone system inhibitors.

Hyperkalaemia occurs in 23% to 47% of patients with chronic kidney disease and/or taking common medication for heart failure, with an estimated 200m and 38m people, respectively, living with each condition worldwide.

Trials showed that it took most patients receiving Lokelma it took 2.2 hours to return to normal potassium levels in the blood, with 92% of patients achieving normal potassium levels within 48 hours.

Chief medical officer Sean Bohen said: "We are pleased by today's FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalaemia. The consequences of hyperkalaemia can be very serious and it's reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors."

Meanwhile, with a Europe regulatory review under way, AstraZeneca submitted a supplemental new drug application for its Forxiga type-1 diabetes treatment to Japan's Pharmaceuticals and Medical Devices Agency.

The application, for Forxiga, a selective sodium-glucose co-transporter 2 inhibitor, is given as an oral adjunct treatment to insulin in adults with type-1 diabetes, follows a Japanese trial Phase III in patients with inadequately controlled type 1 diabetes.

Results showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5mg and 10mg doses.