Ghana is the first country in the world to roll out a malaria treatment specially formulated for newborn babies.

The new treatment, known as Coartum <5 kg Baby, uses a new ratio and dose of artemether-lumefantrine to account for metabolic differences in babies under 5kg. Small babies handle drugs differently due to the immaturity of their metabolising organs

The treatment received regulatory approval in Ghana in February and was also approved by the Swiss agency for therapeutic products, Swissmedic, in July.

Three-quarters of those who die from malaria are children under the age of five. Until now, babies under 4.5 kg with malaria were given formulations designed for older children, which increased either the risk of overdose and toxicity or underdose and treatment failure.

Coartum Baby was developed by Novartis, with support from the Medicines for Malaria Venture (MMV). It was tested in a trial known as CALINA, which was conducted in eight African countries with support from the PAMAfrica consortium, which is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP2).

“These tiny patients handle drugs differently due to the immaturity of their metabolising organs, which can lead to overdose and toxicity. Coartem <5 kg Baby provides optimised dosing specifically tailored to the needs of these vulnerable patients,” according to Novartis in a media release, following the successful conclusion of the CALINA trial.

“Infants under 5 kg can be affected by placental malaria, leading to poor birth outcomes, or contract malaria from the bite of an infected mosquito. The prevalence of the disease in this age and weight group is poorly understood, and it is therefore often misdiagnosed.

“Infants below 5 kg make up a critical neglected group, and developing antimalarials specifically suited to their needs is essential to malaria control efforts,” added Novartis.

Protecting the most vulnerable

“Malaria remains one of the deadliest diseases for children under five years old, and Ghana’s leadership in approving Coartem Baby is a powerful step toward protecting the most vulnerable,” said MMV CEO Dr Martin Fitchet

“This optimised formulation offers a well-tolerated and effective solution to a long-standing unmet medical need.”

Ghana is one of 11 African countries designated by WHO as High Burden to High Impact for malaria. 

About 30 million babies are born in malaria-risk areas in Africa every year, and a large survey across three West African countries reported infections in babies under six months old ranging from 3.4% to as high as 18.4%.

Novartis has committed to introducing Coartem Baby on a largely not-for-profit basis.

This week, Mali recruited the first pregnant woman infected with malaria into a Phase 3 trial that is evaluating the efficacy and safety of antimalarial drugs during the first trimester of pregnancy.

MMV is also supporting this trial, known as SAFIRE,which will compare the safety and efficacy of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP), both approved for the general population but not yet in early pregnancy, to artemether-lumefantrine (AL), which is approved by the WHO for use in the first trimester.

Pregnant women are more susceptible to malaria as they have reduced immunity, and malaria poses serious risks to both mothers and babies.

Malaria in pregnancy is responsible for 20% of all stillbirths and 11% of all newborn deaths in sub‑Saharan Africa, as well as 10,000 maternal deaths globally each year. It can also cause severe maternal anaemia, miscarriage, stillbirth, preterm delivery and low birthweight. 

Image Credits: UNICEF/Zahara Abdul 2019.