WHO Approves First Malaria Drug for Infants; New Single-Dose Compound Shows Promise

The World Health Organization (WHO) has approved the first malaria drug specifically designed for infants, a combination of artemether and lumefantrine that is safe for babies weighing less than 5 kilograms (2.2 pounds). The approval, announced ahead of World Malaria Day on April 25, allows countries to authorize the drug even if they lack the capacity to conduct full clinical trials, and enables UN agencies to procure and distribute the treatment in malaria-endemic areas, subject to government approval. Until now, infants have been treated with drugs developed for older children, which expose newborns to risks of dosing errors and toxicity.

Children under five remain the most vulnerable group, accounting for around 70% of all deaths related to the mosquito-borne disease. Malaria also has a major impact during pregnancy, contributing to an estimated 10,000 maternal deaths, 200,000 stillbirths, and around 550,000 babies born with low birth weight each year, according to the WHO. The new drug closes a medical care gap for 30 million babies born each year in malaria-endemic areas across Africa. Sub-Saharan Africa accounts for nine out of ten malaria cases and deaths globally.

In a separate development, researchers have described a new antimalarial compound, named cabamiquine, as a "significant step forward" in the global fight against the disease. Discovered by a team at the University of Dundee, the molecule is described as a "new molecule with drug-like properties" that can be administered in a single dose and has the potential to simplify dosing regimens for both the prevention and treatment of malaria. Early clinical trials showed that combination therapy with pironaradine was effective and had a favorable safety profile in adults and adolescents, opening up opportunities for further research, including among children. The study, published in The Lancet Infectious Diseases, was conducted by Merck as part of the PAMAfrica consortium and jointly funded by the EDCTP2 program with support from the European Union and the Swedish International Development Cooperation Agency.

Investment in malaria research is yielding significant returns. Every $1 invested in the Medicines for Malaria Venture (MMV) between 2000 and 2023 yielded $13 in monetised health benefits, according to a study published in The Lancet Global Health. Since its launch in 1999, MMV has brought 19 malaria medicines to the market that have treated or protected more than 1.3 billion people worldwide. The total investment received by MMV was $2.3 billion over the 23-year study period, and the antimalarial drugs developed and launched with its support averted an estimated 1.6 million deaths and 87 million disability-adjusted life-years (DALYs). The cost of delivery is estimated to be $785 million. A new Novartis anti-malarial drug designed for newborns and babies under 5kg, developed with MMV, was launched late last year in Ghana, while new treatments for pregnant women have just entered Phase 3 trials.

Malaria kills almost 600,000 people annually (2023 figures), 95% in Africa, with about 282 million cases and over half a million deaths reported in 2024. Since 2000, global efforts have led to significant progress, with an estimated 14 million deaths averted, the WHO says. However, progress against the parasite is stalling, in part because of a lack of resources and the parasite's ability to mutate and develop resistance to antimalarial drugs. Growing resistance to artemisinin, the standard drug of care, is a huge challenge that highlights the need for new products. The WHO forecasts an additional 78 million cases of malaria over the next five years in the absence of new treatments, which could result in 80,000 more deaths each year. Climate-driven extreme weather events and conflict are also increasing the risk of malaria. Earlier this April, the WHO approved three new rapid tests as malaria parasites have evolved to become harder to detect; in countries in the Horn of Africa, up to 80% of cases were found to be missed due to false negatives, which delayed treatment and increased the risk of death. In 2021, the WHO recommended the first malaria vaccine, which was introduced on a large scale, targeting young children in multiple countries in Africa.