The World Health Organization (WHO) has prequalified Novartis’ Coartem (artemether-lumefantrine) Baby as the first malaria treatment specifically designed for newborns and young infants.
In conjunction, the global health agency also prequalified a set of new diagnostic tests aimed at improving malaria detection in hard-to-reach cases.
WHO’s prequalification means the treatment meets international standards for quality, safety and efficacy, enabling UN agencies and global procurement bodies to purchase and distribute it in malaria-endemic regions.
The announcement, made on April 24, 2026, ahead of World Malaria Day, marks a significant step toward closing long-standing gaps in malaria care for the world’s most vulnerable patients.
WHO and partners launched the 2026 World Malaria Day campaign, “Driven to End Malaria: Now We Can. Now We Must,” which calls for protecting lives now and funding a malaria-free future.
The new treatment is an infant-specific formulation of artemether-lumefantrine designed for babies weighing between 2 kg and 5 kg. Until now, infants in this weight group (under 4.5 kg) have typically been treated with scaled-down versions of medicines intended for older children, increasing the risk of dosing errors and safety concerns.
Health experts say the development closes a critical gap. Roughly 30 million babies are born each year in malaria-risk regions of Africa, yet very young infants have historically been underrepresented in clinical trials and underserved in treatment development.
Dr. Daniel Ngamije Madandi, Director of WHO’s Malaria and Neglected Tropical Diseases program, described the new formulation as an important innovation because no previous antimalarial medicine had been specifically designed for children this small.
The treatment was developed in partnership with Novartis and the Medicines for Malaria Venture (MMV), and is expected to be made available largely on a not-for-profit basis in endemic regions.
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Coartem Baby was first approved in Switzerland by Swissmedic in July 2025 through its Global Health Products regulatory pathway, which is designed to speed access to essential medicines for diseases that disproportionately affect low- and middle-income countries. The approval covered its use for treating uncomplicated malaria in newborns and infants weighing between 2 kg and 5 kg.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus framed the development as part of a broader turning point in the fight against malaria, pointing to advances in vaccines, diagnostics, mosquito nets and treatments.
“New vaccines, diagnostic tests, next-generation mosquito nets and effective medicines, including those adapted for the youngest, are helping to turn the tide,” he said. “Ending malaria in our lifetime is no longer a dream, it is a real possibility, but only with sustained political and financial commitment.”
Alongside the treatment approval, WHO also prequalified three new rapid diagnostic tests (RDTs) designed to address emerging challenges in malaria detection.
The most widely used malaria tests rely on detecting a parasite protein called HRP2. However, in some regions, malaria parasites have evolved to delete the gene responsible for producing this protein, making infections invisible to standard tests and leading to false negatives.
According to the WHO, in some areas of the Horn of Africa, up to 80% of cases have been missed using conventional diagnostics, delaying treatment and increasing the risk of severe disease and death.
The new tests detect an alternative parasite marker (pf-LDH), which is less likely to be altered/lost by the parasite, providing a more reliable diagnostic option where HRP2-based tests are failing. WHO now recommends that countries use these alternative RDTs when more than 5% of cases are missed due to pf-hrp2 deletions.
Despite decades of progress, malaria remains a major global health threat. According to the WHO’s World malaria report 2025 estimates, there were roughly 282 million cases and 610,000 deaths in 2024, with children under five accounting for the majority of fatalities.
Although 47 countries have been certified malaria-free and 37 countries reported less than 1,000 cases in 2024, global gains have recently stagnated due to challenges such as drug resistance, insecticide resistance and diagnostic failures.
Still, the combination of new treatments, vaccines and improved diagnostics signals are renewing momentum in the global malaria response.
Malaria vaccines are being deployed by 25 countries, while next-generation mosquito nets account for 84% of all newly distributed nets. Together, these advances highlight what can be achieved when global partners collaborate to innovate and deliver on the goal of ending malaria for all, WHO says.
The agency estimates that malaria interventions have already prevented over 2 billion infections and saved 14 million lives since 2000.
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