AstraZeneca PLC (LON:AZN) has finally received approval from the US Food and Drug Administration for its Lokelma hyperkalaemia treatment.
The drug, formerly known as ZS-9, had been rejected two times previously by regulators, casting doubt over Astra’s US$2.7bn acquisition of ZS Pharma back in 2015, which it primarily bought to gain access to the compound.
READ: FDA deals another blow to Astra’s ZS-9 drug
“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,” said chief medical officer Sean Bohen.
“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.”
Hyperkalaemia is a condition where potassium levels in the blood are dangerously high and can threaten kidney and heart function.
Blockbuster potential
Astra reckons it can generate peak sales in excess of US$1bn a year, with some analysts claiming that the total market is worth upwards of US$6bn.
The approval is key for Astra, which is still in the process of filling the void left by declining sales of its previous blockbusters Crestor and Seroquel drugs.
News of the approval comes just a few days after the FTSE 100 drugmaker reported a sharp fall in first-quarter revenues and earnings per share.
