AstraZeneca’s hyperkalaemia treatment rebounds with European recommendation

pharmafile | February 24, 2017 | News story | Sales and Marketing |  AstraZeneca, EMA 

AstraZeneca have received some positive news on its hyperkalaemia drug, ZS-9, as it received a recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. ZS-9 was hit with a major setback in the form of a CRL by the FDA in May of 2016, delaying its entrance to market.

AstraZeneca need the good news on ZS-9, having shelled out $2.7 billion to acquire ZS Pharma, the developer of the drug, and the CHMP’s positive opinion on the drug are exactly that. CHMP’s matter-of-fact conclusion on the drug reads as follows: “The benefits with Lokelma (ZS-9) are its ability to lower serum potassium levels. The most common side effects are hypokalaemia and oedema related events”.

Hyperkalaemia is the condition of having high potassium levels in the blood, and occurs usually in those patients who have chronic kidney disease and, or as well as, chronic heart failure. The condition can lead to cardiac arrest and death, with 30% of patients experiencing severe hyperkalaemia dying as a result.

The current method of treatment is through a medicine called Veltassa, produced by Relypsa; ZS-9 was thought to be poised to blow the drug out of the water, but the FDA’s rejection of AstraZeneca’s drug kyboshed those short terms plans. ZS-9 is still poised to take over the market, as it is presumed to have a safer profile than Veltassa, which currently has a severe black box warning label due to its interference with other medication.

The approval was based on a Phase 3 study showing that patients who were treated with ZS-9 experienced significantly reduced blood serum potassium levels, bringing readings down to normal levels within 48 hours.

Ben Hargreaves