United Kingdom-based AstraZeneca has received approval from The US Food and Drug Administration (FDA) for its Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, intended for the treatment of hyperkalaemia in adults, it was reported yesterday.
The product is a highly selective, oral potassium-removing agent. It has received approval based on the product receiving authorisation from the European Commission for the treatment of hyperkalaemia in adult patients and it is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials.
AstraZeneca chief medical officer and global medicines development executive vice president, Sean Bohen, said, '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. 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.'
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval