WHO Approves First Malaria Drug for Babies

The World Health Organization (WHO) has approved the world’s first malaria treatment specifically designed for newborns and young infants. This marks a major milestone in global health, as it addresses a long-standing treatment gap for one of the most vulnerable population groups affected by malaria.

About the Drug: 

The newly approved treatment is based on the antimalarial combination Artemether-lumefantrine, formulated in a dose suitable for babies weighing around 2–5 kg. It is the first medicine specifically tailored for infants, unlike earlier treatments that used adjusted doses meant for older children.

Need for the Development:

Earlier, infants suffering from malaria were treated with drugs designed for older children, which increased risks of incorrect dosing, toxicity, and side effects. The new formulation closes this critical gap and ensures safer and more effective treatment for newborns and infants.

WHO Prequalification Significance:

The WHO has granted “prequalification” status to the drug, meaning it meets international standards of quality, safety, and efficacy.

This approval allows:

Procurement by UN agencies and global health organizations

Wider adoption by countries with limited regulatory capacity

Faster distribution in malaria-endemic regions

Development and Distribution:

The drug (commercially known as Coartem Baby) has been developed by Novartis in collaboration with Medicines for Malaria Venture (MMV). It is expected to be distributed largely on a not-for-profit basis in malaria-affected regions, particularly in Africa.

Global Malaria Context:

Malaria remains one of the world’s deadliest infectious diseases:

Around 95% of cases and deaths occur in Africa

Children under five account for nearly 75% of malaria deaths

Millions of babies are born annually in malaria-prone regions

This new drug is expected to significantly reduce infant mortality and improve treatment outcomes.

Additional Key Facts:

Malaria is caused by Plasmodium parasites and transmitted by female Anopheles mosquitoes.

The most dangerous species: Plasmodium falciparum.

Artemisinin-based combination therapies (ACTs) are the standard treatment globally.

WHO has also recommended malaria vaccines such as RTS,S and R21 for children.

Prevention strategies include:

Insecticide-treated bed nets (ITNs)

Indoor residual spraying

Early diagnosis and treatment