GSK plc, in collaboration with Medicines for Malaria Venture (MMV), has revealed that the World Health Organization (WHO) has granted prequalification status to tafenoquine, marking it as the first single-dose treatment aimed at preventing relapses of *Plasmodium vivax* (P. vivax) malaria. Tafenoquine, which is used alongside chloroquine, is now incorporated into WHO’s updated malaria guidelines in South America, marking a landmark recommendation.
This significant development represents a leap forward in bridging the treatment gap for P. vivax malaria, especially as the updated WHO guidelines now advocate its use for both adults and children aged two and above, weighing no less than 10 kg. By offering a single-dose solution, toe-tapping challenges associated with the conventional longer-term regimen are mitigated, which is particularly beneficial for patients experiencing relapsing malaria.
*P. vivax* is the predominant malaria strain in various regions outside sub-Saharan Africa, flourishing across most tropical and subtropical areas globally. Mainly affecting children below five and migrating populations, the challenge of P. vivax lies in its complex lifecycle, consisting of both a visible blood stage and a latent liver stage that can reactivate and cause multiple episodes from one mosquito bite.
Thomas Breuer, Chief Global Health Officer at GSK, emphasized: “The WHO’s prequalification of tafenoquine enables us to positively influence and protect more lives, especially those of children and other at-risk groups. The medicine’s inclusion in the updated WHO malaria guidelines is a cornerstone in our strategy to simplify treatment access for communities burdened by this disease.”
Adding to this sentiment, MMV CEO Martin Fitchet remarked: “Today’s announcement of tafenoquine’s WHO prequalification and guideline inclusion signals transformative progress in malaria treatment. This milestone epitomizes the innovative power and collaboration necessary to stride toward a malaria-free world.”
Tafenoquine, an 8-aminoquinoline, works specifically against the liver stage of P. vivax malaria and stands as an alternative to primaquine, offering advanced protection against malaria relapses in children over two in South America. It affords a `radical cure` by targeting both the blood and liver stages when administered with chloroquine. However, due to the risk of hemolytic anemia in individuals with G6PD deficiency, it’s essential to conduct G6PD testing—a practice facilitated by the quick two-minute ‘STANDARD’ G6PD test developed with PATH and SD Biosensor.
The WHO’s prequalification is vital in ensuring a medicine’s quality, safety, and efficacy for the intended audience, significantly enhancing accessibility to life-saving treatments in low and middle-income regions.
The WHO malaria guidelines undergo regular evaluations by global malaria specialists, leading to this latest inclusion of tafenoquine (150mg tablets and 50mg dispersible tablets) alongside chloroquine within WHO’s recommendations for South America. After launching in Brazil and Thailand, tafenoquine has received approvals in numerous countries affected by P. vivax, with ongoing evaluations for its marketing authorization in other endemic regions.
Originally synthesized in 1978 by Walter Reed Army Institute of Research scientists, tafenoquine is instrumental in managing all *P. vivax* lifecycle stages, including hypnozoites. Beginning over two decades ago, GSK’s dedication to advancing tafenoquine culminated in a 2008 partnership with MMV, propelling this treatment into their global health program and focusing on vulnerable groups worldwide. The STANDARD G6PD test, a joint endeavor by SD Biosensor and PATH, is a handheld device approved by global health bodies.
The *Plasmodium* parasite’s intricate life cycle spans humans and mosquitoes, capable of lying dormant in the liver and periodically reactivating, challenging current treatments.
Global regions such as South Asia, Southeast Asia, Latin America, and the Horn of Africa bear the brunt of *P. vivax* malaria, which attributes to approximately 8.5 million clinical cases each year. The disease is marked by symptoms like fever and chills and can escalate to severe illness, posing considerable public health and economic challenges.
GSK operates as a pioneering biopharmaceutical entity that integrates science, tech, and talent to combat diseases collectively. Meanwhile, MMV, a dedicated Swiss non-profit organization since 1999, seeks to innovate and distribute accessible malaria solutions to foster global health equity.