A malaria drug specifically formulated for newborns and infants weighing less than five kilogrammes will soon be introduced in eight African countries, including Nigeria.
The medicine, artemether-lumefantrine, marketed as Coartem Baby, was developed by Novartis in partnership with the Medicines for Malaria Venture (MMV) and recently authorised by the Swiss agency for therapeutic products (Swissmedic). The approval follows clinical trials conducted in Nigeria, Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Tanzania and Uganda. Ghana has already approved the treatment.
The trial, which was closed early due to strong evidence of safety and efficacy, marks the first time a malaria therapy has been specifically designed for infants under 5kg. Previously, clinicians had to break down tablets intended for older children to approximate doses for newborns, an unsafe practice that posed serious risks.
Under the Swissmedic’s Marketing Authorisation for Global Health Products (MAGHP) process, the participating countries are expected within 90 days to register and approve the medicine through their respective regulatory agencies. The MAGHP pathway is designed to speed up approvals in low- and middle-income countries with limited regulatory capacity.
The Africa Centres for Disease Control and Prevention (Africa CDC) welcomed the development, describing it as a “major advance” in closing a critical treatment gap for Africa’s youngest and most vulnerable.
Africa CDC Director General, Dr Jean Kaseya, said the approval ensures that “even the smallest and most vulnerable infants now have access to safe and effective treatment.” He commended the eight trial countries for their leadership, noting that it reflects Africa’s growing role in driving health innovation.
Kaseya added that the Africa CDC is committed to supporting countries in scaling up access through targeted policies, investments, and collaboration, with the aim of eliminating malaria within a generation.
Also, the agency’s Principal Advisor, Dr Ngashi Ngongo, said the new treatment demonstrates the impact of Africa-led collaboration in delivering solutions where they are most needed.
He assured that the Africa CDC would work with member states to integrate the formulation into health systems by updating clinical guidelines, training health workers, strengthening surveillance, and facilitating equitable access through local manufacturing and the African Pooled Procurement Mechanism.
According to him, the regulatory process will also be fast-tracked under the new reliance mechanism agreed by the eight National Regulatory Authorities, in collaboration with the African Medicines Regulatory Harmonisation initiative (AMRH/AUDA-NEPAD).
Reacting to the development, Professor of Public Health Parasitology at Nnamdi Azikiwe University, Awka, and Founder of the Malaria Eradication and Safe Health Initiative of Nigeria, Prof. Dennis Aribodor, queried Nigeria’s limited role in the process despite being “the malaria capital of the world.”
He urged the Federal Government to take the lead in malaria research by providing funding and safeguarding national interests. Aribodor further stressed the need to establish a functional pharmacovigilance system to monitor adverse drug reactions.
“My hope is that the government will provide the needed resources for pharmacovigilance and start taking effective leadership in the fight against malaria in Nigeria,” he said.
