……Trial paves way for lifesaving therapy for infants under five kilograms
Nigeria has joined seven other African nations in achieving a medical breakthrough with the approval of the first-ever malaria treatment for newborns and infants weighing less than five kilograms.
The Africa Centres for Disease Control and Prevention (Africa CDC), in a statement on Sunday, hailed Nigeria’s contribution to the clinical trial that made the new therapy possible, describing it as “a turning point in the global fight against malaria.”
Until now, babies in this weight category had no approved treatment option. Health workers often resorted to splitting or diluting doses meant for older children, a risky improvisation that could easily result in overdose, toxicity, or treatment failure.
The new drug, a specially formulated artemether-lumefantrin, is designed to dissolve in breast milk, with a mild, sweet taste that makes administration easier for fragile newborns.
Swiss regulators have already granted approval, while Nigeria and other participating countries are expected to fast-track clearance under the Swiss agency’s Marketing Authorisation for Global Health Products procedure.
Africa CDC Director-General, Dr. Jean Kaseya, described the development as a “major step forward” in malaria care.
“This breakthrough ensures that even the smallest and most vulnerable infants can now access safe and effective treatment,” Kaseya said. “It is a move that will save thousands of young lives across the continent.”
Nigeria was joined in the trial effort by Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Tanzania and Uganda, countries that Kaseya commended for “paving the way for an innovation Africa can be proud of.”
Principal Adviser to the Africa CDC Director-General, Dr. Ngashi Ngongo also underscored the significance of the collaboration.
“This achievement shows that Africa can lead in health innovations when countries work together,” Ngongo said. “Nigeria’s role was central to the success of the trials.”
The Africa CDC has pledged to support Nigeria and the other participating countries in swiftly integrating the new drug into their health systems.
Plans include fast-tracking regulatory approvals, updating clinical guidelines, training frontline health workers, and ensuring equitable distribution, particularly in rural and underserved communities.
The drug was developed by pharmaceutical giant Novartis in partnership with the Medicines for Malaria Venture (MMV), under the PAMAfrica consortium.
Novartis has pledged to make the therapy available on a primarily not-for-profit basis to widen access in malaria-endemic countries.
According to the World Health Organisation (WHO), Nigeria bears the world’s heaviest malaria burden , accounting for 27 per cent of global cases and 31 per cent of worldwide malaria deaths.
Children under five are the most at risk, making the arrival of an approved treatment for infants under five kilograms a crucial public health milestone.