On July 8, 2025, Novartis announced a significant advancement in malaria treatment with the approval of Coartem® Baby (artemether-lumefantrine) by Swissmedic, marking it as the first malaria medicine specifically designed for newborns and young infants. This groundbreaking treatment, also referred to as Riamet® Baby in various regions, was developed in partnership with the Medicines for Malaria Venture (MMV) to address the urgent need for effective therapies against this deadly mosquito-borne disease.
The approval from Swissmedic is a pivotal step forward, as it paves the way for rapid approvals in eight African countries under the Marketing Authorization for Global Health Products procedure. These countries, which include Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, collectively account for approximately 47% of estimated malaria cases in 2023, as reported by the WHO.
Novartis aims to distribute Coartem Baby on a largely not-for-profit basis, enhancing accessibility in regions where malaria is endemic. CEO Vas Narasimhan stated, “For more than three decades, we have remained committed to the fight against malaria, striving to deliver scientific breakthroughs where they are most needed.” This new treatment aims to ensure that even the most vulnerable populations, including infants and newborns, receive the necessary care.
Historically, there has been a substantial treatment gap for infants weighing less than 4.5 kilograms, as they have been reliant on formulations designed for older children. This practice posed significant risks, including overdose and toxicity. Furthermore, existing malaria vaccines are not approved for the youngest babies, leaving them particularly vulnerable. Each year, around 30 million babies are born in malaria-endemic areas of Africa, with studies indicating infection rates between 3.4% and 18.4% among infants under six months.
Professor Umberto D'Alessandro from the London School of Hygiene and Tropical Medicine highlighted the risks associated with using untested treatments for infants, noting, “The available malaria treatments have only been properly tested in children aged at least 6 months.” The need for a tailored solution for newborns is critical, given their unique metabolic needs.
The infant-friendly formulation of Coartem Baby was developed with support from MMV and the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. This new treatment is designed to dissolve easily, even in breast milk, and features a sweet cherry flavor to facilitate administration.
Martin Fitchet, CEO of MMV, emphasized the importance of this advancement, stating, “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.”
The Swissmedic approval is based on the Phase II/III CALINA study, which evaluated a new dosing ratio of Coartem for infants under five kilograms. This treatment is specifically indicated for 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.
Malaria remains one of the world's deadliest diseases, particularly affecting children under five years old. According to the latest WHO data, there were 263 million cases of malaria and approximately 597,000 deaths in 2023, with children under five accounting for around three-quarters of these fatalities.
Novartis has dedicated itself to malaria innovation, establishing one of the industry's largest pipelines of treatments aimed at controlling or eliminating malaria and neglected tropical diseases. Since 1999, Novartis has provided over 1.1 billion treatment courses of antimalarials, primarily at no profit, including 500 million treatments of child-friendly formulations for infants weighing at least 5 kilograms.
Through continued investment in global health R&D, Novartis is committed to addressing the challenges posed by malaria and ensuring that innovative solutions like Coartem Baby can reach those who need them the most.
The introduction of Coartem Baby represents a crucial advancement in the fight against malaria, particularly for the youngest and most vulnerable populations. This innovative treatment not only fills a significant gap in malaria care but also underscores the importance of continued research and development in combating deadly diseases that disproportionately affect children in malaria-endemic regions.