GSK Applies for Australian Approval of Malaria Treatment
December 14 2017 - 4:56AM
Dow Jones News
By Adam Clark
GlaxoSmithKline PLC (GSK.LN) said Thursday that it has submitted
a regulatory application in Australia for the approval of a
potential malaria treatment.
The pharmaceutical is seeking approval for single-dose
tafenoquine to treat Plasmodium vivax malaria from Australia's
Therapeutic Goods Administration. The submission includes phase 3
data from previous studies.
Getting the green light in Australia would open the way for
approval in countries where the disease is endemic, said GSK,
adding that it intends to make the treatment available at a
not-for-profit price in such places.
The company said that tafenoquine isn't currently approved for
use anywhere in the world, and that it intends to proceed with
regulatory filings in other countries in 2018.
Write to Adam Clark at adam.clark@dowjones.com;
@AdamDowJones
(END) Dow Jones Newswires
December 14, 2017 05:41 ET (10:41 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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