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Novartis has won approval in Switzerland for the world’s first malaria drug for newborns and infants, creating a new weapon in the fight against the mosquito-borne disease that is deadliest for children under five.
The Swiss pharma group said on Tuesday it had received approval from the Swissmedic official agency for the drug, known as Coartem, to treat infants weighing less than 4.5kg.
It added that eight African countries where malaria was prevalent, including Nigeria, Tanzania and Kenya, had joined the process and were also expected to issue rapid approvals.
There were 263mn cases of malaria and just under 600,000 deaths worldwide in 2023, according to the World Health Organization. Almost all of those were in countries in the WHO’s Africa region, with children under five accounting for more than three-quarters of the fatalities.
Until now, children weighing less than 4.5kg have been treated with drugs intended for older children, which Novartis said had left a “treatment gap” and risked the increase of overdose and toxicity. It added that some 30mn babies were born in areas of malaria risk in Africa each year.
Novartis plans to offer the medicine largely on a not-for-profit basis, to improve access to treatments in areas where malaria is endemic. Global efforts to combat malaria have been rocked by international aid cuts, while the range of the Anopheles mosquito that spreads it is projected to expand because of climate change.
“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, Novartis chief executive.
“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.”
The new treatment, known as Riamet Baby in some countries, was developed in collaboration with Medicines for Malaria Venture. MMV is a Swiss non-profit group working to deliver medicines to treat, prevent and eliminate malaria.
Coartem is an established antimalarial drug based on artemisinin, an extract from sweet wormwood long used in Chinese traditional medicine. Novartis said it had delivered more than 1.1bn treatment courses of antimalarials, mostly at no profit, since 1999, almost half of those for babies weighing at least 5kg.
A new generation of malaria vaccines manufactured by other pharma groups and rolled out with the support of international health institutions are not approved for the youngest babies.
Available malaria treatments have only been properly tested in children aged at least six months, said Umberto D’Alessandro, a professor at the London School of Hygiene and Tropical Medicine.
“That matters because neonates and young infants have immature liver function and metabolise some medicines differently, so the dose for older children may not be appropriate for small babies,” said D’Alessandro.
US plans to slash spending on a flagship campaign against malaria threaten millions more cases and tens of thousands of extra deaths in Africa this year, according to projections published in the Lancet last month.
Donald Trump’s administration proposes to nearly halve the budget of the President’s Malaria Initiative, which was launched 20 years ago under George W Bush.
