Nigeria has been named among eight African countries that participated in a landmark clinical trial which led 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), in a statement on Sunday, commended Nigeria’s role in the breakthrough trial.
According to the News Agency of Nigeria (NAN), the new infant-friendly formulation of artemether-lumefantrine is the first treatment designed specifically for children under five kilograms.
The formulation, which dissolves in breast milk and is sweet-flavoured, was developed to make administration easier for newborns.
Until now, babies in this weight category had no approved malaria therapy, forcing health workers to adjust medicines meant for older children a practice that carried risks of overdose and toxicity.
Swiss regulators have already granted approval for the drug, while Nigeria and the other trial countries are expected to fast-track its clearance under the Swiss agency’s Marketing Authorisation for Global Health Products procedure.
Africa CDC Director-General, Dr. Jean Kaseya, hailed the development as a milestone in the global fight against malaria. “This ensures that even the smallest and most vulnerable infants can now access safe and effective treatment,” he said.
Kaseya added that the new formulation is expected to save thousands of young lives, commending Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Tanzania, and Uganda for their role in the clinical trials.
Dr. Ngashi Ngongo, Principal Advisor to the Africa CDC Director-General, stressed that the achievement underscored Africa’s ability to drive health innovation through collaboration. He described Nigeria’s role as crucial to the success of the trials.
The Africa CDC pledged continued support to ensure countries like Nigeria integrate the new drug into their health systems.
This, the agency said, would involve expediting regulatory approvals, updating clinical guidelines, training health workers, and guaranteeing equitable access, especially in rural and hard-to-reach communities.
The treatment was developed by pharmaceutical giant Novartis in partnership with Medicines for Malaria Venture under the PAMAfrica consortium. Novartis said the drug would be supplied on a primarily not-for-profit basis to ensure wider access across malaria-endemic regions.
Nigeria carries the highest malaria burden globally, accounting for 27 per cent of cases and 31 per cent of deaths, according to the World Health Organisation (WHO).
Children under five remain the most vulnerable group, making the availability of a safe therapy for infants under five kilograms a critical public health milestone.
