Prime Highlights
- Novartis gets Swissmedic approval for Coartem Baby, the first malaria medication to be specifically designed for infants weighing less than 4.5 kg.
- Infant-friendly formulation may break down in breast milk, making it safe and precise to administer at home.
Key Facts
- Approximately 30 million babies are born every year where there is malaria, and
18.4% of babies under the age of 6 months are infected with malaria. - Malaria caused over 597,000 deaths in 2023, with over 95% occurring in sub-Saharan Africa—most among children under five.
Key Background
Malaria remains an international health emergency, particularly in sub-Saharan Africa, where it is most prevalent in children under five. Although older kids and adults have treatments they can receive, newborns that weighed less than 4.5 kg at birth had no licensed malaria medicine until today. Physicians habitually turned to breaking up adult tablets or having to go into emergency hospital care—dangerous and imprecise choices for neonates.
Novartis has addressed this urgent need for treatment with Coartem Baby, a cherry-flavored version of the established artemether-lumefantrine fixed dose combination. Tailored especially for babies who weigh between 2 and 5 kg, the tablet rapidly dissolves in breast milk and thus ensures safe, precise dosing in the home setting. This is an important step forward in the treatment of malaria among children, particularly in remote villages where there are no hospitals.
The medicine has obtained the Swissmedic fast-track approval after concurrent scientific review with regulators of eight countries in Africa. The countries—Kenya, Nigeria, Uganda, and Malawi—are supposed to approve the medicine within 90 days. It is a proof of increased efforts at harmonizing the approvals where the disease of malaria is highly endemic.
Formulated in collaboration with Medicines for Malaria Venture (MMV), Novartis’s Coartem Baby will be made available on a considerably not-for-profit basis. The firm has highlighted its push to make life-saving malaria treatment more accessible in the world’s poorest communities. With more powerful threats arising at the very point when drug resistance and climate change are growing worldwide, advances such as this are required in order to reinforce progress against malaria.
By. aimed at the youngest and most vulnerable patients, Coartem Baby is a breakthrough in the war on malaria—a disease that still prevails to kill hundreds of thousands of people annually.
