Last Updated on July 8, 2025 2:26 pm by BIZNAMA NEWS
- Coartem® (artemether-lumefantrine) Baby becomes first malaria treatment approved for newborn babies and young infants
- Rapid approvals in eight African countries now expected under a special global health scheme run by Swiss agency for therapeutic products (Swissmedic)
- Novartis plans to introduce infant-friendly Coartem Baby on largely not-for-profit basis to increase access in areas where malaria is endemic
AMN / WEB DESK
In a major breakthrough for global child health, Swiss pharmaceutical company Novartis has received regulatory approval for Coartem, the world’s first malaria treatment specifically developed for babies and very young children. The approval was granted by Swiss authorities, marking a critical advancement in the fight against malaria, particularly in regions with high infant mortality rates due to the disease.
This approval holds immense significance, as the majority of malaria-related deaths globally occur in children under the age of five, with Africa accounting for most of these fatalities. In 2023 alone, malaria caused over 500,000 deaths worldwide, with infants and toddlers representing the most vulnerable demographic.
Until now, infants were treated using adjusted doses of malaria medication formulated for older children—an approach that posed serious risks such as incorrect dosing, reduced effectiveness, and increased chances of adverse reactions.
With the regulatory green light now secured, production and distribution of Coartem are expected to commence in the coming weeks, beginning in African countries where the need is most urgent. Health experts have welcomed the development as a lifesaving innovation that could substantially reduce child mortality rates in malaria-endemic regions.
The formulation of Coartem for infants is seen as a game-changer in pediatric malaria care, offering safer, more reliable treatment for the youngest and most at-risk population.
“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.”
Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap. They have instead been treated with formulations intended for use in older children, which may increase the risk of overdose and toxicity. Malaria vaccines are also not approved for the youngest babies.2
Some 30 million babies are born in areas of malaria risk in Africa every year,3 with one large survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than 6 months old.4 However, current data on malaria in young babies is extremely limited as they are rarely included in clinical trials of antimalarial agents.5,6
“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.”
The new dose strength designed for young infants was developed by Novartis with the scientific and financial support of MMV, and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer.
“Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,” said Martin Fitchet, CEO of MMV. “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.”
About the CALINA study
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. It is indicated for the treatment of 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. Coartem is known by the brand name Riamet in Switzerland and some other countries.
About malaria
Malaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.7
About Novartis in malaria innovation
Novartis finds breakthroughs for diseases neglected by science and brings innovative medicines to communities on the margins of healthcare, building on 85 years of innovation in global health. 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 just completing Phase III trials, and another which is a potential single-dose cure. 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.