Breakthrough Malaria Treatment For Babies Set To Launch Across Africa.
A groundbreaking development in the fight against malaria has been announced, with the approval of the first-ever malaria treatment specifically designed for newborns and young infants. The medicine, Coartem Baby (also known as Riamet Baby in some regions), developed by Swiss pharmaceutical company Novartis in collaboration with the Medicines for Malaria Venture (MMV), is poised to address a critical gap in paediatric healthcare. This milestone, approved by Swissmedic, Switzerland’s regulatory authority, marks a significant step forward in protecting Africa’s most vulnerable children from one of the continent’s deadliest diseases.
Malaria remains a devastating public health challenge, claiming approximately 597,000 lives globally in 2023, with nearly three-quarters of these deaths occurring among children under five in Africa, according to the World Health Organization (WHO). Until now, no malaria treatment was specifically formulated for infants weighing less than 4.5 kilograms, forcing healthcare providers to use drugs designed for older children. This practice carried significant risks, including potential overdose and toxicity, due to the immature liver function of newborns, which affects how they metabolise medications. Coartem Baby, tailored for babies weighing between 2 and 5 kilograms, offers an optimised dose and a cherry-flavoured, dissolvable formulation that can be mixed with breast milk, making it easier and safer to administer.
The approval of Coartem Baby follows rigorous clinical trials, including the Phase II/III CALINA study, which demonstrated its safety and efficacy for the youngest patients. Eight African nations—Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—participated in the drug’s assessment and are expected to grant their own approvals within weeks under the Swissmedic Marketing Authorization for Global Health Products (MAGHP) procedure. Ghana has already approved the treatment, paving the way for its imminent rollout. Novartis has committed to distributing the medicine on a largely not-for-profit basis, ensuring greater access in malaria-endemic regions.
“This is a historic moment in the global fight against malaria,” said Vas Narasimhan, CEO of Novartis. “For decades, we’ve worked to deliver scientific breakthroughs where they’re needed most. Coartem Baby ensures that even the smallest and most vulnerable children can receive the care they deserve.” Martin Fitchet, CEO of MMV, echoed this sentiment, stating, “Malaria is one of the world’s deadliest diseases, particularly for children. This approval is a vital step toward reducing its toll and moving closer to elimination.”
The significance of this development cannot be overstated. Approximately 30 million babies are born annually in malaria-risk areas across Africa, with studies indicating that between 3.4% and 18.4% of infants under six months contract the disease. Historically, these newborns have been overlooked in clinical trials due to the complexities of testing treatments on such young patients. Professor Umberto D’Alessandro, Director of the MRC Unit at the London School of Hygiene and Tropical Medicine, noted, “The lack of properly tested treatments for infants under six months has been a significant gap. Coartem Baby addresses this by providing a clinically proven solution tailored to their unique needs.”
The rollout of Coartem Baby is expected to begin in the coming weeks, with the eight participating African countries prioritising areas with the highest malaria burden. This initiative complements ongoing efforts to combat malaria, including the distribution of insecticide-treated bed nets, chemoprevention, and the introduction of malaria vaccines like RTS,S/AS01 and R21. In 2024, 17 African countries integrated malaria vaccines into their routine childhood immunisation programmes, vaccinating millions of children. The WHO estimates that combining these vaccines with other interventions could save tens of thousands of young lives annually.
Dr Marvelle Brown, Associate Professor at the University of Hertfordshire’s School of Health, Medicine and Life Sciences, hailed the approval as a “major breakthrough” in saving young lives, particularly in sub-Saharan Africa, where over 76% of malaria deaths occur in children under five. She highlighted the compounded risks for babies born with conditions like sickle cell disease, which weaken their immune systems. “This treatment fills a critical gap and offers hope to families across the continent,” she said.
As Africa prepares to roll out Coartem Baby, the initiative underscores the continent’s growing role in global health innovation. The collaboration between African nations, Novartis, and MMV demonstrates the power of partnerships in addressing longstanding health inequities. With rapid approvals expected and distribution set to begin this autumn, this new treatment promises to protect countless newborns and infants, bringing Africa closer to a future free from the scourge of malaria.
