Key Highlights :
Novartis receives approval for first malaria drug specifically for newborns and young infants.
Coartem Baby offers low-dose, cherry-flavored granules for babies 2–5 kg.
Rapidly accelerated approval includes collaboration with WHO and eight African regulators.
Key Background :
Malaria is still a serious public health problem, particularly in sub-Saharan Africa where the majority of cases and mortality occur. In just 2023, the WHO reported more than 263 million malaria cases worldwide and an estimated 600,000 deaths. Alarmingly, more than three-quarters of these deaths were related to children under five years old. Newborn babies and less than six months old infants are most vulnerable and in the past were not eligible for age-related, approved malaria treatments.
Until recently, patients in this age range had received modified doses of drugs originally formulated for children or adults—most often crushed pills or off-label dosing. These practices had posed several problems, including inexact dosing, increased risk of side effects, and inconsistent drug absorption. Clinicians have long advocated for the immediate creation of special preparations in light of the unique metabolic profiles and body sizes of neonates.
Novartis has designed Coartem Baby, which particularly addresses such issues. It is artemether and lumefantrine, old, well-established antimalarials, but reworked as a granule preparation for infants. Cherry-flavored granules are designed to break down in liquids like breast milk, thus becoming easy to give and increasing compliance. The medication was able to pass trials which established the right dose and proved its safety and effectiveness in infants weighing 2 to 5 kilograms.
Swissmedic’s approval under its MAGHP program was facilitated through World Health Organization coordination and national regulation from eight African countries. Its multi-country review model should accelerate regional approvals, with many African countries able to approve the drug in the next three months. This will bring timely access in regions of greatest malaria burden.
Medical professionals have received the innovation favorably. Specialists emphasized the importance of developing medicines specifically for infants, citing their unique physiology and dangers of using modified adult drugs. Rollout of Coartem Baby has been considered a valuable contribution to global malaria control measures, complementing vaccination campaigns and control measures against mosquitoes.
Novartis reasserted its dedication to global health today by declaring that Coartem Baby would be sold on a not-for-profit basis to endemic nations. It is a continuation of its long history of disease eradication efforts, including the supply of over 1.1 billion antimalarial treatments since 1999. With drug resistance and funding issues undermining progress, the launch of Coartem Baby brings fresh hope for protection of the youngest and most vulnerable.
