Coartem® Baby: First Malaria Treatment for Newborns and Infants

• Coartem® (artemether-lumefantrine) Baby becomes the first approved malaria medicine specifically for newborns and young infants.

• Rapid approvals are anticipated in eight African nations under a special health initiative managed by Swissmedic.

• Novartis intends to launch Coartem Baby primarily on a not-for-profit basis to enhance access in malaria-prone regions.

Basel, July 8, 2025 – Novartis has announced that Coartem® (artemether-lumefantrine) Baby has received approval from Swissmedic, marking it as the first malaria treatment for newborns and very young infants. This new option, referred to as Riamet® Baby in certain places, was developed alongside Medicines for Malaria Venture (MMV) to combat this critical mosquito-borne illness.

Eight African countries were involved in the assessment process and are expected to grant quick approvals through Swissmedic’s Marketing Authorization for Global Health Products procedure. Novartis aims to provide this infant-friendly treatment on a largely not-for-profit basis to increase availability in areas affected by malaria.

“For over three decades, we’ve focused on the battle against malaria, striving to deliver scientific advancements where they are essential,” stated Vas Narasimhan, CEO of Novartis. “We are thrilled to collaborate with partners to create the first clinically verified malaria treatment for newborns, ensuring the most vulnerable among us can finally receive proper care.”

Previously, there was no approved malaria treatment for infants under 4.5 kilograms, leaving a significant gap in care. They have often been treated with medications intended for older children, which might pose a risk of overdose or toxicity. Additionally, malaria vaccines aren’t currently authorized for the youngest infants.

In Africa alone, about 30 million babies are born annually in malaria-prone areas, with a large survey from West Africa showing infection rates in infants younger than six months ranging from 3.4% to 18.4%. Unfortunately, data about malaria in very young infants is scarce since they are often excluded from medication trials.

“Existing malaria treatments have largely been tested in children at least six months old, as younger infants tend to be excluded from studies,” noted Professor Umberto D’Alessandro from the London School of Hygiene and Tropical Medicine. “This is critical because newborns have immature liver functions, altering how they metabolize some medicines. Therefore, dosages for older children may not be suitable for them.”

The new dosage created for young infants was established by Novartis with support from MMV, as part of the PAMAfrica consortium, which receives funding from several international organizations. This treatment is designed to dissolve, including in breast milk, and features a cherry flavor, making it easier to administer.

“Malaria is one of the deadliest diseases on the planet, particularly affecting children. With adequate resources and attention, it can indeed be eradicated,” mentioned Martin Fitchet, CEO of MMV. “The approval of Coartem Baby provides a vital treatment with a tailored dose for this often-overlooked group of patients, adding value to our arsenal against malaria.”

About the CALINA Study
The approval granted by Swissmedic is based on the Phase II/III CALINA study, which explored a new dosing ratio of Coartem to address metabolic differences in babies under five kilograms. It targets infants weighing between two and less than five kilograms with acute, uncomplicated Plasmodium falciparum infections. In Switzerland and some other nations, Coartem is marketed under the brand name Riamet.

About Malaria
Malaria is a severe illness caused by a parasite transmitted through certain mosquitoes. According to the latest WHO statistics, there were 263 million malaria cases in 2023, leading to 597,000 deaths, primarily in Africa. Notably, around 75% of malaria fatalities in the region occur among children under five years of age.

About Novartis and Malaria Innovation
Novartis is dedicated to finding solutions for diseases neglected by research, producing innovative treatments for underprivileged communities. Over 85 years, the company has focused on developing malaria treatments and neglected tropical diseases, investing nearly USD 490 million into global health R&D since 2021. Among these efforts are new antimalarial compounds aimed at combating rising drug resistance. Novartis has provided over 1.1 billion antimalarial treatment courses, primarily at no profit, including 500 million doses of child-friendly formulations for larger infants.