World’s First Malaria Drug Approved for Newborns and Underweight Babies
In a major breakthrough for global health, Swiss medical authorities have approved the first-ever malaria treatment specifically designed for newborns and infants weighing under 11 pounds. The newly authorized medicine, named Coartem Baby (also known as Riamet Baby), addresses a long-standing treatment gap for one of the most vulnerable groups affected by the disease.
Targeting a Critical Treatment Gap
Developed through a collaboration between Medicines for Malaria Venture (MMV) and Swiss pharmaceutical giant Novartis, Coartem Baby combines two key antimalarial ingredients—artemether and lumefantrine—already used in older children and adults. The approval now allows its use in infants weighing between 4.4 and 11 pounds, a category that previously had no approved treatment options.
According to Swissmedic, Switzerland’s health regulatory body, the new formulation is “a significant step forward in the global fight against malaria,” especially for very young and malnourished children who have historically been underserved.
Global Impact of Malaria
Despite being both preventable and treatable, malaria remains a major global health challenge. In 2023, the disease affected 263 million people and caused over 597,000 deaths, according to the World Health Organization (WHO). Children under five remain most at risk, accounting for around 76% of malaria deaths in Africa alone.
Safe and Easy to Administer
Coartem Baby has been developed with ease of use in mind. The treatment is dissolvable in water or breast milk and features a sweet cherry flavor to ensure higher acceptance among infants. These features aim to reduce the need for complex hospital treatments or tablet grinding, which many families in malaria-endemic regions have had to rely on.
Wider Availability in Africa
The drug has already been authorized for use in collaboration with eight African nations:
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Burkina Faso
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Ivory Coast
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Kenya
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Malawi
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Mozambique
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Nigeria
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Uganda
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Tanzania
Local regulatory approvals are expected within 90 days of submission, allowing timely access to the treatment across the continent.
Expert Reactions
Bhargavi Rao, co-director at the London School of Hygiene and Tropical Medicine, praised the move, noting that even low levels of malaria parasites in newborns can lead to serious illness or death. She added that the new formulation, which can be easily mixed with breast milk, is a major step forward for care delivery in resource-limited settings.
Part of a Broader Fight
This approval comes amid wider efforts to combat malaria through both vaccinations and vector control. As of April, 19 countries have begun rolling out malaria vaccines for children aged 5 months and above, according to WHO.
Novartis CEO Vas Narasimhan said the company is proud to have created “the first clinically proven malaria treatment for newborns and young babies,” and plans to make the medication available on a largely non-profit basis in malaria-endemic regions.
The Road Ahead
With 95% of malaria deaths occurring in Africa, public health experts continue to call for increased funding for preventive tools like bed nets, medications, and vaccines. Climate change is also extending mosquito breeding seasons, raising concerns that over 5 billion people may be at risk of malaria by 2040, including 1 billion in Africa alone.
While some researchers explore advanced tools like gene-editing technologies to reduce mosquito populations, others caution that such approaches raise important ethical and ecological questions.
