
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.
The new medicine, Coartem Baby by Novartis, is the first malaria drug cleared for children weighing under 4.5 kilograms (10 lbs).
For years, doctors have relied on Coartem to treat uncomplicated malaria, but there was no formulation for the youngest, most vulnerable patients.
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.
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.
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.
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.
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.
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.
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)