Zurich: Pharmaceutical giant Novartis has announced that it has received regulatory approval in Switzerland for Coartem Baby, the world’s first antimalarial drug specifically developed for newborns and very young infants. The company noted that this formulation, known in certain regions as Riamet Baby, addresses a critical treatment gap in managing malaria in infants under 4.5 kg (9.9 lbs).
Following the Swiss authorization, eight African nations that participated in a joint regulatory review process are now expected to move forward with their approvals. These include Uganda, Ivory Coast, Kenya, Tanzania, Nigeria, Burkina Faso, Mozambique, and Malawi. Novartis introduced Coartem in 1999 for the first time to combat malaria.
The paediatric formula was later tailored to suit the unique needs of young patients. It was developed in collaboration with the Medicines for Malaria Venture (MMV)— a non-profit organisation that worked towards the treatment and prevention of malaria. The infant version of this medicine dissolves in water or breast milk and is flavoured with cherries for enhancement of taste.
To date, infants under 4.5kg in weight have limited access to treatment options, as most of the anti-malaria drugs have only been tested on children aged six months or more. In most cases, healthcare providers were asked to adjust dosage for older children, which resulted in inappropriate or excessive dosage. Moreover, the currently available malaria vaccines are not yet approved for the youngest infants.
According to Novartis, roughly 30 million babies are born each year in regions of Africa where malaria remains endemic. Data collected across parts of West Africa reveal that malaria infections in babies under six months old range from 3.4% to 18.4%, highlighting the urgent need for safe, age-appropriate treatments.
Novartis has committed to the distribution of Coartem Baby on a non-profit basis, aiming to maximise access in areas where people have limited resources. Novartis CEO said, “We are proud to offer the first clinically validated malaria treatment tailored specifically for newborns and small infants. This advancement ensures that even the most vulnerable can now receive the care they desperately need.”
With this move, Novartis reinforces its role in global public health by closing a longstanding treatment gap for one of the most at-risk populations in the fight against malaria.