GSK Applies for Australian Approval of Malaria Treatment

By Adam Clark Features Dow Jones Newswires

GlaxoSmithKline PLC (GSK.LN) said Thursday that it has submitted a regulatory application in Australia for the approval of a potential malaria treatment.

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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

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December 14, 2017 05:41 ET (10:41 GMT)