A Breakthrough for Newborns: First Malaria Drug for the Tiniest Patients Approved

A game-changing pediatric malaria drug, Coartem Baby, wins Swiss approval offering first-ever treatment for newborns under 4.5 kg, with rollout planned in eight African nations by year-end.

The image shows a compassionate nurse holding a newborn.

Coartem Baby: The first approved malaria drug for newborns under 4.5 kg marks a major leap in pediatric healthcare across malaria-endemic African nations.AI image

Published on:

11 Jul 2025, 4:09 pm

Major Milestone in Pediatric Malaria Treatment

The fight against malaria has reached a new milestone with the Swiss regulatory authority’s approval of a treatment specifically for newborns and young infants. This advance is expected to accelerate access to life-saving care in eight African countries before the end of 2025.

What Makes Coartem Baby Special

The new medicine, Coartem Baby by Novartis, is the first malaria drug cleared for children weighing under 4.5 kilograms (10 lbs).

This is an important addition to the management of malaria in high-burden countries.

Dr. Jane Achan, principal adviser, Malaria Consortium.

For years, doctors have relied on Coartem to treat uncomplicated malaria, but there was no formulation for the youngest, most vulnerable patients.

Fast-Tracked Approval in Africa

Eight African nations-Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda were part of the approval process with Swissmedic. These countries accounted for nearly half of the 263 million global malaria cases in 2023.

It’s the quickest way to include as many countries as possible in a harmonized and stringent regulatory procedure.

Lutz Hegemann, Novartis’ president of global health & Swiss country affairs,

Rollout of Coartem Baby may begin before the year’s end. In Uganda, Dr. Achan shared, the registration process has started, and she expects access to be realistic by year’s end.

This formulation is quite timely and very important,

Dr. Jane Achan, principal adviser, Malaria Consortium.

Addressing an Urgent Gap

Until now, clinicians faced the challenge of adapting existing treatments by guessing at smaller doses, a method that risked underdosing or overdosing and potential neurotoxicity.

Just changing the dose is not going to work because you might either underdose or overdose one of the two components. That can lead to neurotoxicity. We had to change the ratio between the two active ingredients.

Lutz Hegemann, Novartis’ president of global health & Swiss country affairs.

Commitment to Access and Fair Pricing

Novartis will offer Coartem Baby primarily on a not-for-profit basis, but the final price will be determined after its public launch. Dr. Achan is not expecting pricing to be a barrier, since the medication is a reformulation of an existing treatment and is likely to be included in the procurement processes of the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Challenges in Demand and Diagnosis

The true demand for the new medicine is still unknown because malaria cases among newborns and infants are relatively poorly studied. Hegemann indicated Novartis can meet any level of demand. Meanwhile, Dr. Achan pointed out, training healthcare workers to recognize malaria in the youngest patients remains crucial, as symptoms often go unnoticed.

That might help spur greater testing and diagnoses of malaria in newborns and infants.

Dr. Jane Achan, principal adviser at the Malaria Consortium.

Key Questions Answered

Why is a special medicine for newborns needed?

Newborns require precisely formulated doses for safe and effective treatment. Altering existing formulations risks improper dosing and potential side effects.

How soon might this medicine reach hospitals?

The rollout could begin in some African countries before the end of the year, with Uganda already progressing toward registration.

Will cost prevent access?

The medicine is expected to be affordable as Novartis plans to provide it mainly at cost and expects coverage via established global health programs.

We have heard from patients how critical that situation is when a baby has a life-threatening disease and there isn’t an approved treatment. That prompted us to embark on this journey.

Lutz Hegemann, Novartis’ president of global health & Swiss country affairs.

Human Impact

Novartis will continue to monitor demand and outcomes as more infants receive this new medicine. Meanwhile, doctors, parents, and global health advocates watch with hope that Coartem Baby will help rewrite the story of malaria for Africa’s youngest generation.

(Rehash/Dr. Divina Johncy Rosario/MSM/SE)

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