Infectious diseases

First Malaria Treatment for Newborns Approved by Swiss Regulators

Published JUL 8 2025

Story

Above: U.S. Army medical researchers participate in World Malaria Day 2010 in Kisumu, Kenya. Image credit: Wikimedia Commons

The Facts

Novartis announced Tuesday that Switzerland's drug regulator, Swissmedic, approved Coartem Baby, the world's first malaria treatment specifically designed for newborns and infants weighing less than five kilograms.
Bloomberg.com
EuroNews
Eight African countries, including Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, participated in the approval process and are expected to rapidly authorize the medicine within 90 days under Swissmedic's global health procedure.
The Washington Post
Sky News
The treatment is dissolvable with a sweet cherry flavor that can be mixed with breast milk, making administration easier for the youngest patients who previously received inappropriate doses of medications designed for older children.
Devex
GlobeNewswire News Room
The new formulation addresses metabolic differences in infants whose immature liver function processes medicines differently than older children, reducing risks of overdose and toxicity that previously occurred when using standard pediatric doses.
Devex
EuroNews
Novartis plans to distribute Coartem Baby on a largely not-for-profit basis in malaria-endemic regions, with rollout expected to begin in Africa within weeks, following the successful Phase II/III CALINA study results.
Semafor
EDCTP
GlobeNewswire News Room
Malaria killed approximately 597,000 people globally in 2023, with children under five accounting for about three-quarters of deaths in Africa, while an estimated 30 million babies are born annually in malaria-risk areas across the continent.
The Washington Post
Pharmaceutical Technology
Reuters

Sources Split

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The Spin

Narrative A

This breakthrough is a crucial step forward in protecting the world's most vulnerable population from a highly preventable disease. The cherry-flavored, breast milk-dissolvable formulation finally gives healthcare workers an appropriate tool for treating newborns who were previously at risk of dangerous overdoses from adult medications.

BBC News

www.ft.com

Narrative B

While this development fills a significant gap, the focus should remain on prevention through existing tools, such as bed nets and vaccines, rather than expanding treatment options. The relatively modest burden of malaria in newborns compared to older children suggests resources might be better allocated to proven prevention strategies.