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First Malaria Drug Approved for Newborns and Small Babies, Coartem Baby

By I. Edwards HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on July 9, 2025.

WEDNESDAY, July 9, 2025 — A new malaria treatment has been approved for newborns and infants under 11 pounds, filling a major gap in care for some of the most vulnerable children.

The medicine, called Coartem Baby (also known as Riamet Baby), was approved by Switzerland’s health agency, Swissmedic, The Washington Post reported.

It was developed by the Geneva-based nonprofit Medicines for Malaria Venture and the Swiss drug company Novartis.

“The newly authorized product addresses a critical treatment gap for one of the most vulnerable patient populations — young infants suffering from malaria,” Swissmedic said in a statement.

Malaria is caused by a parasite spread through mosquito bites. It’s preventable and treatable, but sickened 263 million people worldwide in 2023 and claimed nearly 600,000 lives, according to World Health Organization (WHO) data.

Children under 5 are especially at risk. In Africa alone, they made up 76% of malaria deaths, the WHO reports.

Bhargavi Rao, co-director of the Malaria Center at the London School of Hygiene and Tropical Medicine, said the new drug will be especially helpful for very small and malnourished babies, who often don’t qualify for standard treatments.

“Traditionally, people had said that small babies didn’t get malaria because they were protected by maternal immunity, but I think we’re increasingly recognizing that the burden in very small children is not insubstantial, and they just present in very different ways. Even very low levels of parasites can give fairly significant, severe malaria and death,” Rao told The Post.

“This is a drug that can be mixed with breast milk, which is brilliant and much easier to deliver,” she said.

Coartem Baby contains two medicines — artemether and lumefantrine — that work together to fight the malaria parasite. These drugs were already approved for use in patients weighing over 11 pounds.

The new version:

• Is approved for infants weighing 4.4 to 11 pounds.

• Dissolves easily, including in breast milk.

• Has a sweet cherry flavor to make it easier to give to infants.

The treatment was approved under Swissmedic’s Marketing Authorization for Global Health Products (MAGHP), which helps speed access to medicines for diseases affecting sub-Saharan Africa, The Post said.

So far, eight African countries have signed on to review and approve the treatment. They are Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Uganda, and Tanzania. Once submitted for review, these countries are expected to authorize the drug within 90 days.

Malaria vaccines are also now available in many countries. Children can start getting vaccinated around 5 months of age, according to WHO. By April of this year, vaccines were being rolled out in 19 countries due to what WHO called "unprecedented" demand.

Still, medicines are needed to treat babies too young for the vaccine or those who become infected anyway.

Novartis said it plans to offer the new treatment on what is essentially a nonprofit basis in places where malaria is common.

“[We’re] proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve," Novartis CEO Dr. Vas Narasimhan said.

In all, 95% of all malaria deaths happen in WHO’s Africa region, the organization said. Many families lack access to basic tools like mosquito nets or medicines, The Post said.

Experts say climate change is making the situation worse. Longer mosquito seasons and rising temperatures could put more than 5 billion people at risk for malaria by 2040, including 1 billion in Africa alone.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted July 2025

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