Basel, Switzerland | July 8, 2025 — In a revolutionary move for pediatric malaria care, Novartis has announced that its new infant-formulated antimalarial medicine, Coartem® (artemether-lumefantrine) Baby, has been officially approved by Swissmedic, the Swiss Agency for Therapeutic Products. This regulatory milestone marks the first-ever approval of a malaria treatment specifically indicated for newborns and young infants weighing between 2 and less than 5 kilograms.

The treatment, also known as Riamet® Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) and addresses a critical unmet need in malaria treatment for neonates and small infants, a group previously excluded from approved antimalarial therapies due to the lack of age-appropriate formulations.

“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,”

“Together with our partners, we are proud to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the most vulnerable can receive the care they deserve.” – Dr. Vas Narasimhan, CEO of Novartis.

A Solution for an Overlooked Population

Until yesterday, no approved malaria treatments existed for infants under 4.5 kilograms. Healthcare providers were often forced to use medicines formulated for older children, raising the risk of inaccurate dosing, increased toxicity, andineffective treatment. This new formulation fills a significant treatment gap, particularly in sub-Saharan Africa, where over 30 million babies are born annually in malaria-endemic regions.

The medicine, which comes in a sweet cherry-flavored, dissolvable form, can be administered easily, including with breast milk, and has been optimized for neonatal physiology, considering their immature liver function and unique drug metabolism needs.

“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,”

“This approval finally provides a safe, effective option tailored to how newborns metabolize medications.” – Professor Umberto D’Alessandro, Director of the MRC Unit in The Gambia at the London School of Hygiene and Tropical Medicine.

Accelerated Access in Africa Through Global Health Scheme

The approval by Swissmedic was granted under the Marketing Authorization for Global Health Products (MAGHP)procedure, which enables simultaneous reviews with national regulatory authorities from participating countries. As a result, eight African countries that took part in the joint assessment are expected to issue rapid approvals of the treatment in the coming weeks and months.

Novartis plans to introduce Coartem Baby in malaria-endemic countries on a largely not-for-profit basis, reinforcing its commitment to equity and global health access. The company has already delivered over 1.1 billion antimalarial treatments since 1999, with 500 million doses tailored for children.

Global Partnerships

The approval is based on findings from the Phase II/III CALINA study, which tested a newly optimized artemether-lumefantrine dose ratio specifically for infants below 5 kg. The study demonstrated that the formulation is effective in treating acute, uncomplicated Plasmodium falciparum infections, as well as mixed infections including P. falciparum.

The medicine’s development was supported by MMV and funded under the PAMAfrica Consortium, which receives co-financing from the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Swedish International Development Cooperation Agency (SIDA).

“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.” – Dr. Martin Fitchet, CEO of MMV.

About Malaria

Malaria is a parasitic disease transmitted to humans through the bites of infected mosquitoes. According to the World Health Organization (WHO), 263 million malaria cases and 597,000 deaths were recorded globally in 2023. Children under five remain the most affected group, accounting for approximately 75% of malaria-related deaths in Africa.