AstraZeneca’s FDA delayed ZS-9 gains European thumbs-up

The drug, known as Lokelma, should be available in Europe later this year.

Held up last year at the FDA by manufacturing issues, AstraZeneca has been granted a much-needed recommendation from the EMA for its $2.7 billion hyperkalemia drug ZS-9, now known (in Europe at least) as Lokelma (sodium zirconium cyclosilicate).

AstraZeneca bought the drug from its 2015 multibillion-dollar buyout of ZS Pharma and was on track for what seemed a slam-dunk approval from the FDA, but was hit with a complete response letter over manufacturing issues coming out of its biotech buy.

This put it further behind rival Relypsa, a company that already markets its hyperkalemia treatment Veltassa, with both looking to compete in a market potentially worth $6 billion.

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AstraZeneca has since resubmitted its med to the FDA, but alongside a clutch of recommendations posted today has gained the CHMP green light in Europe, with a final approval expected in the coming months.

Lokelma will be available as 5-g and 10-g powder for oral suspension and works by selectively binding potassium in exchange for hydrogen and sodium cations throughout the GI tract and reduces the concentration of free potassium in the GI lumen.

This, the CHMP notes, has the effect of lowering serum potassium levels by drawing potassium into the GI tract and increasing fecal potassium excretion to resolve hyperkalemia.

The CHMP also noted that the most common side effects were “hypokalemia and edema related events.”

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