Novartis announced that Swissmedic has approved Coartem Baby (artemether-lumefantrine) as the first malaria treatment specifically for newborns and young infants.

Developed in collaboration with Medicines for Malaria Venture (MMV), the new medicine addresses a critical gap in treating malaria in infants weighing less than 4.5kg.

Eight African countries participated in the assessment of Coartem Baby and are expected to issue rapid approvals under Swissmedic’s Marketing Authorisation for Global Health Products procedure.

Novartis aims to introduce the infant-friendly treatment on a largely not-for-profit basis to enhance access in malaria-endemic regions.

Novartis CEO Vas Narasimhan said: “For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most.

“Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”

Previously, there was no approved malaria treatment for infants under 4.5kg, forcing the use of formulations meant for older children, which posed risks of overdose and toxicity.

In addition, malaria vaccines have not been approved for the youngest infants, further highlighting the need for this treatment.

According to a survey across West Africa, malaria infection rates are between 3.4% and 18.4% in infants younger than six months.

However, data on malaria in young babies is limited due to their exclusion from clinical trials of antimalarial agents.

The new dose strength for young infants was developed by Novartis with support from MMV and the PAMAfrica consortium.

Also, it is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.

The treatment is dissolvable, including in breast milk, and has a sweet cherry flavour to facilitate administration.

MMV CEO Martin Fitchet said: “Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated.

“The approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.”