In a landmark development for child healthcare, Nigeria has joined seven other African countries in contributing to clinical trials that led to the approval of the first malaria drug formulated specifically for newborns and infants weighing under five kilograms.
The Africa Centres for Disease Control and Prevention (Africa CDC) celebrated the milestone in a statement on Sunday, noting that Nigeria’s involvement was critical to the achievement.
The treatment—an infant-friendly artemether-lumefantrine—dissolves in breast milk and features a sweet taste to aid ingestion. This represents the first safe and approved malaria medication for babies in this category, closing a dangerous treatment gap that forced health workers to improvise with unsuitable dosages.
Swiss regulators have already approved the drug, while Nigeria and other trial countries are preparing to accelerate approval under a special international procedure designed for global health products.
Dr. Jean Kaseya, Africa CDC’s Director-General, described the development as “a major step forward in the fight against malaria,” noting its potential to save thousands of infant lives.
Dr. Ngashi Ngongo, Principal Advisor to the Africa CDC Director-General, emphasized that the project highlights Africa’s strength in driving health solutions through cooperation, singling out Nigeria’s active role in ensuring the trial’s success.
The Africa CDC announced that it would assist participating countries with regulatory processes, clinical guideline updates, healthcare worker training, and expanding equitable access to the new formulation.
Novartis, working with the Medicines for Malaria Venture under the PAMAfrica consortium, developed the new drug. The pharmaceutical company confirmed that it will distribute the product mostly on a not-for-profit basis in malaria-endemic regions.
WHO data reveals that Nigeria carries the highest global malaria burden, recording about 27 percent of cases and 31 percent of deaths worldwide. With children under five being the most vulnerable group, the approval of a dedicated treatment for underweight infants marks a breakthrough moment for Nigeria’s public health system.