Switzerland’s drug regulator has approved the world’s first malaria treatment for newborn babies, clearing the way for the medicine to become available in parts of Africa where the life-threatening disease is endemic.
In a late-stage clinical trial, pharmaceutical giant Novartis showed the drug was safe and effective for babies weighing less than five kilograms, which they typically reach by two months of age.
Traditionally, these infants have been given either a full or half-dose of the antimalarial drug intended for babies six months or older. But because newborns do not process medicines the same way, there is a higher risk of side effects.
The lack of specialised treatment – and the fact that babies are not vaccinated until they are around five months old – has left the youngest infants relatively unprotected against malaria, a mosquito-borne disease that kills about 597,000 people per year.
Most deaths are among children under five years old in Africa.
It’s not clear exactly how many babies are affected, but in 2023, there were an estimated 36 million pregnancies in 33 African countries where malaria is widespread. About one in three mothers were infected with malaria while pregnant, raising the risk that they will pass the disease along to their newborns, according to the World Health Organization (WHO).
“Every one of those [babies] is a potential target for malaria infection,” Dr Lutz Hegemann, president of Novartis’ global health programme, told Euronews Health.
“We don't want to leave any patient behind, no matter how small they are”.
Eight African countries – Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda – are expected to quickly approve the medicine as part of a partnership with Swissmedic, the Swiss drugs regulator.
Hegemann said Novartis hopes to roll the medicine out there this autumn, with more countries to follow, on a not-for-profit basis.
The medicine, known as Coartem Baby, is similar to Novartis’ existing drug to treat uncomplicated malaria in young children, but it has a different dose and ratio of ingredients to prevent side effects in the youngest infants.
It also has a sweet cherry flavour and can be dissolved in breast milk to make it easier to give to patients.
“These are small changes, but big steps,” Dr Quique Bassat, head of the Barcelona Institute of Global Health, told Euronews Health.
While the number of newborns with malaria “still remains relatively modest in terms of the overall burden, those cases need to be treated, and therefore we need better drugs,” he added.
“Now we have something which is perfectly suitable for that specific age group where there was a gap”.
Bassat advised Novartis on the clinical trial, which was funded by the European Union and the Swedish International Development Cooperation Agency.
