World’s First Malaria Treatment for Newborns Approved

In a groundbreaking step for pediatric healthcare, Switzerland’s drug regulator, Swissmedic, has approved Coartem Baby—the world’s first malaria treatment specifically designed for newborn babies and infants under five kilograms (about 11 pounds). This approval fills a critical gap in malaria care and paves the way for the medicine’s introduction in several African countries where malaria is endemic (constantly present and widespread).

Developed by pharmaceutical giant Novartis in partnership with Medicines for Malaria Venture (MMV), a Swiss non-profit focused on combating malaria, Coartem Baby is an infant-specific formulation of the company's existing drug Coartem, which was first launched in 1999 to treat uncomplicated malaria. Unlike the original version, Coartem Baby features a different dose and ratio of ingredients carefully tailored for newborns’ metabolism to reduce the risk of side effects, as newborns process medicines differently than older children or adults.

Previously, infants weighing less than 4.5 kilograms (9.9 pounds) had no approved treatment for malaria, often receiving either full or half-doses of medications formulated for children aged six months and older. This off-label use carried a higher risk of adverse effects, including overdosing, because these treatments were never clinically tested in newborns — a group usually excluded from early-phase drug trials.

The new drug formulation is dissolvable in breast milk and has a sweet cherry flavor, which improves palatability and makes it easier for caregivers to administer. These features, though seemingly small, mark a major improvement in drug delivery for this vulnerable age group.

Clinical trials supported by the European Union and the Swedish International Development Cooperation Agency demonstrated that the drug is both safe and effective for newborns. These trials were advised by experts like Dr. Quique Bassat, head of the Barcelona Institute of Global Health, who emphasized the urgent need for targeted treatments in newborns, even if the number of cases remains relatively modest.

While precise figures are difficult to confirm, malaria remains a major cause of child mortality, killing around 597,000 people annually, most of them children under five in Africa. In 2023 alone, there were approximately 36 million pregnancies in 33 African countries where malaria is prevalent. Alarmingly, the World Health Organization (WHO) estimates that one in three pregnant women in these regions contracted malaria, significantly increasing the risk of transmitting the infection to their newborns.

This development is especially important considering malaria vaccines are not approved for infants under five months old, making early life an unprotected window for many children. According to Novartis, about 30 million babies are born each year in areas of high malaria risk. In one survey across West Africa, infection rates among infants younger than six months ranged from 3.4% to 18.4%.

In a collaborative and accelerated regulatory approach, eight African countries—Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—took part in the medicine’s assessment alongside Swissmedic. These nations are now expected to rapidly approve and implement Coartem Baby, with Novartis aiming to begin distribution as early as this autumn, and on a largely not-for-profit basis to ensure accessibility.

Novartis CEO Vas Narasimhan hailed the approval as a vital breakthrough, stating:

“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.”

Dr. Lutz Hegemann, president of Novartis’ global health program, added that

“Every one of those babies is a potential target for malaria infection. We don't want to leave any patient behind, no matter how small they are.”

This innovation, also known as Riamet Baby in some countries, marks a significant milestone in the fight against malaria and highlights the ongoing importance of equitable access to healthcare innovations, especially for the world’s most vulnerable populations.

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