Amanze ChinonyeIn a major step toward reducing child mortality, Swiss health authorities have approved the first malaria treatment specifically designed for newborns and infants under 4.5kg.
The drug, known as Coartem Baby marketed as Riamet Baby in some countries was developed by pharmaceutical giant Novartis in collaboration with the Medicines for Malaria Venture (MMV).
Join our WhatsApp ChannelThe approval, which was announced on Tuesday, 8 July 2025, closes a critical treatment gap that has long left millions of the world’s youngest and most vulnerable patients without access to safe, effective antimalarial care.
Until now, malaria-infected newborns and infants have had to rely on medicines formulated for older children or adults, increasing the risk of improper dosing and dangerous side effects. Health experts have long warned that this posed a serious threat to children in malaria-endemic regions, especially in sub-Saharan Africa, where malaria remains a leading cause of death in children under five.
The World Health Organisation (WHO) estimates that nearly 600,000 people died of malaria in 2023, with over 75% of those deaths occurring among children under the age of five most of them in Africa. Infants weighing under 4.5kg have historically had no approved treatment tailored to their weight or metabolic needs, leaving clinicians with few safe options for care.
Coartem Baby is designed specifically for this neglected group. The formulation comes as a cherry-flavored, dispersible tablet that dissolves in water or breast milk, making it easier to administer to sick infants.
The drug was tested in a clinical trial called CALINA, which involved over 200 newborns and infants between 2 and 5 kilograms in weight. The trial, conducted across eight African countries, proved the medicine to be safe and effective when administered at adjusted doses suited to neonatal physiology.
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Vas Narasimhan, CEO of Novartis, said the approval represents a defining moment in the fight against malaria. “Together with our partners, we are proud to have developed the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,” he said.
The eight African countries involved in the clinical trial Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda are expected to be among the first to receive the new treatment. Novartis announced that the medicine will be distributed on a not-for-profit basis, further improving access in low-income settings. The rollout is expected to begin within months.
Martin Fitchet, CEO of MMV, called the approval “an essential step” toward reducing the high toll malaria takes on children each year. He emphasized that until now, a critical group of patients newborns under 4.5kg had been left behind in global malaria strategies.
Dr. Marvelle Brown, a public health expert and associate professor at the University of Hertfordshire, described the development as a “major breakthrough.” She noted that children born with sickle cell disease, common in malaria-prone regions, are even more susceptible due to compromised immune systems, making the availability of a safe treatment particularly vital.
The approval was granted under Switzerland’s Marketing Authorization for Global Health Products program, which facilitates the rapid registration of essential medicines in low-and middle-income countries. The initiative helps accelerate access to life-saving treatments in regions where the burden of disease is greatest.
Approximately 30 million babies are born each year in malaria-endemic areas. Studies suggest that up to 18% of infants under six months are infected with malaria, making timely access to treatment essential. Until now, malaria vaccines have not been approved for children under five months old, further heightening the need for neonatal drug therapies.
While the new drug provides hope for reducing child mortality, global health experts warn that its impact depends on sustained funding, supply chain readiness, and support from governments and aid organizations. Recent proposed budget cuts to key global health programs in donor countries, including the U.S. President’s Malaria Initiative, have raised concerns about future access to malaria interventions in Africa.
Nevertheless, health officials and humanitarian groups are optimistic that the arrival of Coartem Baby will help transform malaria care for infants across the continent.
Amanze Chinonye is a rising star in the literary world, weaving captivating stories that transport readers to the vibrant landscapes of Nigeria. With a unique voice that blends tradition with modernity, Chinonye's writing is a masterful exploration of the human condition, delving into themes of identity, culture, and social justice. Through her words, Chinonye paints vivid portraits of everyday Nigerian life, from the bustling markets of Lagos to the quiet villages of the countryside. With a keen eye for detail and a deep understanding of the complexities of Nigerian society, Chinonye's writing is both a testament to the country's rich cultural heritage and a powerful call to action for a brighter future. As a writer, Chinonye is a true storyteller, using her dexterity to educate, inspire, and uplift readers around the world.
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