Aug. 17, 2025
Nigeria has been named among eight African countries that contributed to a clinical trial leading to the approval of the first malaria treatment for newborns and infants weighing less than five kilograms.
The Africa Centres for Disease Control and Prevention (Africa CDC) applauded Nigeria for its role in the trials in a statement on Sunday.
The treatment, an infant-friendly artemether-lumefantrin, is the first of its kind for children under five kilograms.
It dissolves in breast milk and comes with a sweet flavour to make administration easier for newborns.
Until now, babies in this weight category had no approved malaria treatment.
Health workers often had to modify doses of medicines meant for older children, a practice that carried the risk of overdose and toxicity.
Swiss regulators have already approved the formulation, while Nigeria and the 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 breakthrough as major step forward in the fight against malaria.
According to Kaseya said, it ensures that even the smallest and most vulnerable infants can now access safe and effective treatment.
He said that the trial led to the approval of the first malaria treatment designed for newborns and infants under five kilogrammes — a move expected to save thousands of young lives.
Kaseya also commended Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Tanzania and Uganda for their leadership in paving the way for the new formulation.
Dr. Ngashi Ngongo, Principal Advisor to the Africa CDC Director-General, said that the development highlighted Africa’s ability to drive health innovations through collaboration, stressing that Nigeria’s role was key to the success of the trials.
The Africa CDC pledged to support countries like Nigeria to integrate the new formulation into their health systems.
Novartis developed the drug in partnership with the Medicines for Malaria Venture (MMV) under the PAMAfrica consortium.
Novartis said that it would supply the treatment on a primarily not-for-profit basis to expand access in malaria-endemic regions.
According to the World Health Organisation (WHO), Nigeria bears the world’s highest malaria burden, accounting for about 27 per cent of global cases and 31 per cent of global malaria deaths.
Children under five remain the most vulnerable group, making the availability of a safe treatment for infants under five kilograms a major public health milestone for the country
