EU approves label update for AZ’ Lokelma
Update provides dosing regimen specifically for hyperkalaemia in patients with end-stage renal disease on stable haemodialysis
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Tag: sodium zirconium cyclosilicate
US clears label update for AZ’ Lokelma
The drug’s label now includes a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on stable hemodialysis
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NICE turns down hyperkalaemia therapies
Preliminary guidelines released by the National Institute for Health and Care Excellence do not recommend NHS funding for hyperkalaemia treatments Lokelma and Veltassa.
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Second US rejection for AZ’ potassium binder
AstraZeneca’s hyperkalaemia treatment ZS-9 has suffered another setback on the path to US approval having been rejected by regulators for the second time. The drug giant also unveiled a US-based partnership with Circassia for development and commercialisation of COPD drugs Turdoza and Duaklir.
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Six new medicines endorsed for EU approval
Six new medicines, including the first hormone replacement therapy for a thyroid disorder, have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
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FDA accepts resubmission of AZ’ potassium-binder
US regulators have accepted AstraZeneca unit ZS Pharma’s resubmission of ZS-9, a potassium-binding compound being developed for hyperkalaemia.
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