GSK has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of single-dose tafenoquine to cure patients with Plasmodium vivax (P. vivax) malaria.

If approved, the therapy would be the first new medicine in more than 60 years that can be potentially used to prevent the relapse of P. vivax malaria in patients aged 16 and above.

The Plasmodium parasite is a complex organism with a lifecycle spanning both humans and mosquitoes.

With an infected mosquito bite, the P. vivax parasite has the ability to lie dormant in the liver (hypnozoites) and periodically reactivate, causing relapses of P. vivax malaria even weeks or years after the initial infection.

A single P. vivax infection can give rise to multiple episodes of malaria even in the absence of a new mosquito bite.

Tafenoquine is an investigational eight-aminoquinoline derivative with activity against the P. vivax lifecycle, including hypnozoites.

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“Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver, resulting in relapses.”

The drug will potentially address the need for a single-dose and effective medicine for the debilitating disease.

GSK Global Health Research and Development head Pauline Williams said: “Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver, resulting in relapses.

“Poor compliance to primaquine in real-world settings can lead to higher relapse rates than those seen in the controlled setting of clinical trials, so a single dose treatment is an attractive proposition.”

The current NDA submission is based on the Phase III data obtained from the previously reported GATHER and DETECTIVE studies conducted by GSK in partnership with Medicines for Malaria Venture (MMV).

In 2008, the two organisations entered a collaboration to develop tafenoquine as an anti-relapse therapy for patients infected with P. vivax.

GSK also plans to progress regulatory filings in other countries both this year and in 2018.