Coartem Baby, Novartis's first malaria treatment for newborns and infants, has received Swiss approval

What does it represent?

A novel pediatric formulation of artemether-lumefantrine, called Coartem Baby, is tailored for infants weighing 2–5 kg (newborns to less than 6 months).

Created by:

Novartis, together with Medicines for Malaria Venture (MMV) and various global health collaborators.

Goal:

To address the treatment gap for malaria in the most at-risk age group — newborns and young infants, who have been previously left out of clinical trials and vaccination programs.

Main Characteristics:

Easily dissolves, even in breast milk.

Cherry-flavored to promote improved compliance in infants.

Clinically evaluated dosage ratio for infants with underdeveloped liver function.

Authorized by Swissmedic’s Marketing Authorization for Global Health Products scheme.

Will be primarily provided on a not-for-profit basis in countries where malaria is prevalent.

Importance:

Addresses a vital public health need: no malaria medications had been authorized for infants weighing less than 4.5 kg.

Enhances safety by removing off-label dosing from formulations for older children.

Anticipated to receive approval shortly in eight African countries: Kenya, Tanzania, Uganda, Nigeria, Malawi, Mozambique, Burkina Faso, and Ivory Coast.

Tackles malaria threat for approximately 30 million newborns delivered each year in Africa's endemic regions.