Antimalarial Tafenoquine Granted 'Breakthrough' Status

Miriam E. Tucker

December 20, 2013

The US Food and Drug Administration (FDA) has granted "breakthrough therapy" designation for the investigational antimalarial drug tafenoquine.

The decision was announced by codevelopers GlaxoSmithKline and the Medicines for Malaria Venture, a product development partnership. Tafenoquine is not yet licensed anywhere in the world. As a candidate drug for a serious and/or life-threatening condition, the FDA's breakthrough designation will allow for it to receive accelerated development and review times.

Tafenoquine is an 8-aminoquinoline derivative that targets Plasmodium vivax malaria, including a form that lies dormant in the liver and causes relapse of infection within weeks to months of the initial mosquito bite.

An estimated 70 million to 390 million clinical cases of uncomplicated malaria caused by P. vivax occur annually with significant public health and economic consequences in South and East Asia, Latin America, and the horn of Africa.

The drug, administered in a single dose, would be indicated for both malaria treatment and relapse prevention.

In a just-published phase 2b dose-ranging study of 329 patients enrolled across 7 sites in Brazil, Peru, India, and Thailand during September 2011- March 2013, relapse-free efficacy at 6 months was significantly improved with tafenoquine coadministered with chloroquine compared with other therapies, with improvements of 51.7% compared with chloroquine alone and 39.9% compared with primaquine plus chloroquine. Adverse events were similar between treatments.

A Phase 3 study is planned for 2014, according to the GSK/MMV statement.

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