AstraZeneca receives positive CHMP recommendation for hyperkalaemia drug
AstraZeneca has received a positive recommendation for its treatment of a condition caused by cardiovascular, renal and metabolic diseases.
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Following the FTSE 100 drug company's ongoing trials of its ZS-9 drug -- sodium zirconium cyclosilicate, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of its use for the treatment of hyperkalaemia, a serious condition characterised by high potassium levels in the blood.
The CHMP's opinion will now go before the European Commission to decide whether ZS-9 will receive a EU-wide marketing authorisation of the medicine, in which case it could applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
The trials, which have seen more than 1,600 patients treated so far, include a Phase III study that showed hyperkalaemia sufferers had their blood serum potassium returned to normal levels within 48 hours after taking sodium zirconium cyclosilicate and that this was maintained during 12 days of maintenance therapy.
Normal levels of potassium in the blood serum were also achieved within 48 hours in an additional study, with a higher proportion of patients maintaining normokalaemia for up to 28 days on treatment versus placebo.
AstraZeneca's trials have found sodium zirconium cyclosilicate significantly lowers serum potassium levels quickly and effectively in patients with acute and chronic hyperkalaemia.
Hyperkalaemia occurs in 23-47% of patients with chronic kidney disease and/or chronic heart failure and can lead to cardiac arrest and death.
"As current therapy options are limited, sodium zirconium cyclosilicate has the potential to address a long-standing unmet need for the fast, safe and effective long-term treatment of hyperkalaemia," the company said.