The first drug to treat infants sick with malaria is approved by Swiss
authority
[July 09, 2025]
By JAMEY KEATEN
GENEVA (AP) — Switzerland's medical products authority has granted the
first approval for a malaria medicine designed for small infants, touted
as an advance against a disease that takes hundreds of thousands of
lives — nearly all in Africa — each year.
Swissmedic gave a green light Tuesday for the medicine from Basel-based
pharmaceutical company Novartis for treatment of babies with body
weights between 2 and 5 kilograms (nearly 4½ to 11 pounds), which could
pave the way for hard-hit African nations to follow suit in coming
months.
The agency said that the decision is significant in part because it's
only the third time it has approved a treatment under a fast-track
authorization process, in coordination with the World Health
Organization, to help developing countries access needed treatment.
The newly approved medication, Coartem Baby, is a combination of two
antimalarials. It is a lower dose version of a tablet previously
approved for other age groups, including older children.
Dr. Quique Bassat, a malaria expert not affiliated with the Swiss
review, said the burden of malaria in very young children is “relatively
low” compared to older kids.
But access to such medicines is important to all, he said.
“There is no doubt that any child of whichever age — and particularly
very, very young ones or very light-weighted ones — require a
treatment,” said Bassat, the director- general of the Barcelona
Institute for Global Health, known as ISGlobal.

Up to now, antimalarial drugs designed for older children have been
administered to small infants in careful ways to avoid overdose or
toxicity, in what Bassat called a “suboptimal solution” that the newly
designed medicine could help rectify.
“This is a drug which we know is safe, we know works well, and therefore
it will just be available as a new version for a specific age group,” he
said.
Ruairidh Villar, a Novartis spokesperson, said that eight African
countries took part in the assessment and are expected to approve the
medicine within 90 days. The company said that it's planning on a
rollout on a “largely not-for-profit basis” in countries where malaria
is endemic.
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This 2014 photo made available by the U.S. Centers for Disease
Control and Prevention shows a feeding female Anopheles gambiae
mosquito, known vector for the parasitic disease malaria. (James
Gathany/CDC via AP, File)
 Dr. Bhargavi Rao, co-director of the
Malaria Centre at the London School of Hygiene and Tropical
Medicine, noted that malaria cases continue to rise — especially in
crisis-hit countries — despite new vaccines and programs targeting
the mosquitoes that spread the parasite.
She said access strategies for the new medicine must include a look
at where needs are greatest, and urged clarity on pricing.
“We need transparency around what Novartis’ ‘largely not for profit’
statement means including publicly available pricing, which
countries will benefit and how long for,” she wrote in an email.
Still, she said it was “significant to finally have a suitable and
safe treatment for very young children — more than 20 years since
WHO first pre-qualified Coartem for older age groups.
She noted the announcement comes as resistance to antimalarials has
been growing and many traditional donor countries have been sharply
cutting outlays for global health — including for malaria
programming and research.
The mosquito-borne illness is the deadliest disease in Africa, whose
1.5 billion people accounted for 95% of an estimated 597,000 malaria
deaths worldwide in 2023, according to WHO. More than three-quarters
of those deaths were among children.
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