Kenya is among eight African nations that played a key role in clinical trials for a new malaria treatment designed specifically for newborns, marking a major milestone in the fight against the disease. Other participating countries include Nigeria, the Democratic Republic of Congo, Burkina Faso, Mali, and Zambia.

The treatment, known as Coartem Baby (also marketed as Riamet Baby), recently received regulatory approval from Swissmedic, Switzerland’s drug authority.

It is the first antimalarial therapy developed specifically for newborns and young infants weighing between two and under five kilograms.

Developed through a collaboration between Medicines for Malaria Venture (MMV) and pharmaceutical company Novartis, the new formulation is a cherry-flavored, dissolvable powder that can be mixed with breast milk designed to make administration easier and safer for infants.

MMV noted that the countries involved in the trials are expected to fast-track national approvals under Swissmedic’s Global Health Products process.

Clinical trials (Phase II and III) confirmed an adjusted dosage ratio of artemether and lumefantrine, optimized for newborns with Plasmodium falciparum or mixed infections.

Novartis intends to distribute the drug on a mostly not-for-profit basis to ensure affordability across malaria-endemic countries.

MMV CEO Martin Fitchet emphasized that while malaria remains one of the deadliest diseases for children, it can be eliminated with sustained investment and scientific innovation. “Coartem Baby addresses a critical treatment gap for an often-overlooked patient group,” he said.

Currently, no approved malaria treatment exists for infants under 4.5 kg. Health workers have historically adapted adult or child formulations for newborns a method that lacked safety data and posed potential toxicity risks.

With approximately 30 million babies born every year in malaria-prone regions of Africa and infant infection rates ranging between 3.4% and 18.4% in some areas the urgency for a safe and effective newborn-specific treatment has been high.

In Kenya, where 75% of the population lives in malaria-risk zones, the disease continues to take a heavy toll.

According to the World Health Organization, 11,478 deaths were attributed to malaria in Kenya in 2023.

The Ministry of Health estimates about 10,700 deaths annually, the majority of them among children under five, with over 3.5 million clinical cases reported each year.

Dr. Simon Kariuki of the Kenya Medical Research Institute (KEMRI) welcomed the development, calling Coartem Baby a breakthrough.

“We finally have a safe and effective drug specifically for babies under five kilograms. That’s a major step forward,” he said.

The new formulation was developed under the PAM Africa Consortium, supported by the European & Developing Countries Clinical Trials Partnership and Sweden’s International Development Cooperation Agency.

Novartis CEO Vas Narasimhan reaffirmed the company’s long-standing commitment to the malaria fight, saying, “We’ve spent over 30 years driving scientific progress against malaria and this innovation will help protect some of the most vulnerable patients.”