FDA accepts review of AstraZeneca drug for hyperkalaemia

The US Food and Drug Administration has accepted a complete re-submission of a new drug application for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia by AstraZeneca’s subsidiary ZS Pharma.

AstraZeneca

9,990.00p

15:45 15/11/24

-2.93%

-302.00p

FTSE 100

8,060.61

15:45 15/11/24

n/a

FTSE 350

4,453.56

15:45 15/11/24

n/a

FTSE All-Share

4,411.85

15:45 15/11/24

n/a

Pharmaceuticals & Biotechnology

19,259.77

15:45 15/11/24

-2.70%

-535.19

Hyperkalaemia – high potassium levels in the blood serum – commonly occurs in patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death.

AstraZeneca said the FDA has indicated this is a complete class 2 response.

Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.