Novartis has received Swiss regulatory approval for the first malaria treatment specifically designed for newborns and young infants, marking a significant breakthrough in addressing a critical treatment gap that has left the most vulnerable patients without appropriate therapeutic options.
The Swiss pharmaceutical company's Coartem Baby (also known as Riamet Baby in some countries) is indicated for treating infants and neonates weighing between 2 and less than 5 kilograms with acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum. The treatment is expected to be rolled out in African countries within weeks.
Addressing Critical Treatment Gap
Until now, no approved malaria drugs existed specifically for babies weighing less than 4.5 kilograms. Instead, these vulnerable patients were treated with versions formulated for older children, presenting significant safety risks.
"The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials," said Professor Umberto D'Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. "That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies."
This treatment gap has been particularly concerning given malaria's devastating impact on young children. In 2023, malaria was linked to approximately 597,000 deaths, with almost all occurring in Africa and around three-quarters involving children under five years old.
Clinical Development and Approval
The Swissmedic approval is based on the Phase II/III CALINA study, which investigated a new ratio and dose of Coartem (artemether-lumefantrine) to account for metabolic differences in babies under 5 kilograms. The new dose strength was developed by Novartis with scientific and financial support from the Medicines for Malaria Venture (MMV) and as part of the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
The treatment has been formulated to be dissolvable, including in breast milk, and features a sweet cherry flavor to facilitate administration to young patients.
Global Health Impact
Eight African countries participated in Swissmedic's Marketing Authorization for Global Health Products (MAGHP) procedure for Coartem Baby – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda. These nations are expected to approve the medicine following Swissmedic's approval and account for 47% of estimated malaria cases in 2023, according to the WHO's Global Health Observatory.
"For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most," said Vas Narasimhan, CEO of Novartis. "Together with our partners, we are proud to have gone further to develop 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."
Not-for-Profit Distribution
Novartis plans to introduce Coartem Baby on a largely not-for-profit basis, continuing the company's commitment to global health equity. Since 1999, Novartis has delivered more than 1.1 billion treatment courses of antimalarials, mostly at no profit, including 500 million treatments of a child-friendly formulation for babies weighing at least 5 kilograms.
Martin Fitchet, CEO of MMV, emphasized the significance of this development: "Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated. The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox."
Broader Malaria Context
According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, with children under 5 years old accounting for about three in four malaria deaths in Africa. The disease burden is further compounded in babies born with sickle cell disease, primarily due to weak immune systems.
Dr. Marvelle Brown, associate professor at the University of Hertfordshire's School of Health, Medicine and Life Sciences, described this as "a major breakthrough in saving the lives of babies and young children," noting that "the death rate for malarial infections, particularly in sub-Saharan Africa is extremely high - over 76% of deaths occur in children under five years old."
Novartis has built the industry's largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases, backed by nearly USD 490 million in funding for global health R&D since 2021. This includes four new antimalarial compounds with the potential to combat rising drug resistance, one of which is completing Phase III trials, and another which is a potential single-dose cure.
