Artemether/Lumefantrine

Basel: Swiss pharma major Novartis announced that its brand ‘Riamet’ has been approved by the Swissmedic as the first malaria medicine for newborns and young infants The new treatment is developed by Novartis in collaboration with Medicines for Malaria Venture (MMV) and the drug development program was co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. Commenting on the announcement Vas Narasimhan, CEO, Novartis said, “For more than three decades, we have stayed the course in the fight against malaria, and 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.” Riamet also marketed under the brand name coartem in several countries 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. The oral tablets is a combination of artemether and lumefantrine where artemether acts as a fast-acting artemisinin derivative that kills malaria parasites in the early stages of development while the later eliminates remaining parasites and helps prevent recurrence. The approval is based on the positive efficacy and safety data from 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. Besides Europe the drugmaker is expecting rapid approvals in the eight African countries that also participated in the assessment are now expected to issue rapid approvals under the Swiss agency’s Marketing Authorization for Global Health Products procedure. As per the company release Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic. By Online Bureau ,

BASEL, Switzerland I July 8, 2025 I Novartis today announced Coartem ® (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants. The new treatment, also known as Riamet ® Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) to treat the potentially deadly mosquito-borne disease. Eight African countries also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency’s Marketing Authorization for Global Health Products procedure. 1 Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic. “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. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . About MMV MMV is a Swiss not-for-profit working to deliver a portfolio of accessible medicines with the power to treat, prevent and eliminate malaria. Born in 1999 to drive health equity, MMV closes critical gaps in research, development and access – to expand the use of existing antimalarials and innovate new compounds. This starts with women and children. As of 2024, MMV-supported products have effectively treated more than 711 million patients. For more information, visit www.mmv.org Follow MMV on social media: X , LinkedIn , YouTube and Facebook References SOURCE: Novartis