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.'
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15