WHO Approves First Malaria Drug for Babies in ‘Major Public Health Milestone’

The World Health Organization (WHO) has officially approved Coartem Baby, the first malaria treatment specifically designed for newborns and infants, marking a significant turning point in the global fight against one of the world’s deadliest diseases.

Filling a Long-Standing Treatment Gap

The WHO’s prequalification of Coartem Baby means the drug can now be formally deployed in malaria-endemic regions. The treatment can be safely administered to infants as small as 2 kilograms (4.4 pounds) — a critical capability in parts of Africa where malaria is most prevalent.

Prior to this approval, infants with malaria had been treated with formulations designed for older children, which significantly increased the risk of dosing errors, adverse side effects, and toxicity.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus said: “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. But today, the story is changing.”

Dr. Martin Fitchet, chief executive of Medicines for Malaria Venture (MMV), called the WHO ruling “a major public-health milestone.” He noted: “For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind.”

Drug Development Background

Coartem Baby was jointly developed by multinational pharmaceutical company Novartis and MMV. It contains two antimalarial drugs — artemether and lumefantrine — a combination therapy that has proven highly effective and safe in adults and older children.

Novartis said it would make the treatment available “on a largely not-for-profit basis in malaria-endemic regions,” ensuring the drug reaches those who need it most.

Real-World Impact

The treatment has already been introduced in several countries. Dr. Emmanuel Aidoo, a paediatrician at Methodist Hospital in Ankaase, Ghana, described the challenges faced in clinical practice: “As doctors we have tended to look for malaria in older children, but when newborn babies got sick nobody seemed to know what to do.”

“Having a new treatment tailor-made for infants that is well tolerated gives us confidence,” Dr. Aidoo added.

A mother named Naomi shared her experience: “I was very scared when my son got malaria because he was born underweight.” Thanks to the hospital’s ability to coordinate access to Coartem Baby, her child is now healthy and thriving.

New Hope in Global Malaria Control

The WHO noted that alongside Coartem Baby’s approval, new vaccines, diagnostic tests, and next-generation mosquito nets are helping to turn the tide against the mosquito-borne disease. However, malaria remains one of the world’s most destructive infectious diseases, claiming hundreds of thousands of lives annually — the vast majority of them children under five.

In recent years, increasing research has challenged long-held assumptions about malaria treatment in infants, driving targeted development for this vulnerable population. Coartem Baby’s approval is the direct result of these efforts.

With climate change and population movements potentially expanding malaria’s geographic reach, this drug designed specifically for the most vulnerable population represents a crucial advance in global disease control.

Source: The Guardian