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GSK gains a PRV alongside FDA approval for recurring malaria treatment

After two decades of R&D work, GSK has scored an FDA OK for its recurring malaria med, earning a valuable priority review voucher along the way.

Krintafel (tafenoquine) has been approved to prevent the relapse of a type of malaria induced by the Plasmodium vivax parasite, which can not only cause an acute malaria episode at the first mosquito bite but also lie dormant in the liver and reactivates occasionally, causing relapses.

David Reddy

There’s one approved med to target dormant forms of P. vivax — or hypnozoites — that requires a 14-day regimen to be effective. According to GSK, their single-dose drug, to be taken with other antimalarial therapies mean to treat the acute infection, would reduce issues with compliance.

Joining GSK in celebrating the news is Medicines for Malaria Venture, the not-for-profit drug research partnership that helped GSK position the drug for the relapse indication.

“Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most,” said MMV CEO David Reddy.

The R&D team at GSK — now led by Hal Barron — has a submission pending at Australia’s regulatory agency, which they filed just a month after their US NDA. If that comes through, they plan to leverage the two approvals in appealing to the authorities in countries where malaria runs rampant.

They’ve also been awarded a tropical disease priority review voucher, which was meant to encourage development of drugs that target certain neglected tropical diseases.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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