AstraZeneca Treatment for Hyperkalemia Gets EU Approval
March 22 2018 - 1:56PM
Dow Jones News
By Dimitrios Kontos
AstraZeneca PLC (AZN.LN) said Thursday that the European
Commission has granted it marketing authorization for Lokelma, a
treatment for adults with hyperkalemia.
The pharmaceutical company said the approval is supported by
data from three double-blind, placebo-controlled trials and one
open-label trial, where patients were treated for up to 12 months.
Hyperkalemia is a condition in which there are excess levels of
potassium in the blood, which can lead cardiac arrest and
death.
In the trials, patients receiving Lokelma had normalized blood
potassium levels in about 2.2 hours on average, with 98% at normal
levels within 48 hours from baseline, the company said.
Lokelma is also under regulatory review in the U.S., where a
decision is expected in the first half of 2018, the company
said.
Write to Dimitrios Kontos at dimitrios.kontos@dowjones.com
(END) Dow Jones Newswires
March 22, 2018 13:41 ET (17:41 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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