Switzerland’s medical regulatory authority, Swissmedic, has granted approval for Coartem Baby, the first antimalarial drug specifically designed for newborns and infants weighing between 2 kg and 5 kg, reported The Hindu. Developed by global healthcare company Novartis in collaboration with the Medicines for Malaria Venture, this marks a historic first in the fight against malaria—bringing a much-needed solution for the most vulnerable age group.
Until now, infants diagnosed with malaria had no approved treatment option. Healthcare workers and caregivers often resorted to adjusting dosages of medications meant for older children—crushing tablets or diluting syrups—leading to inconsistencies in dosing and safety concerns. Coartem Baby addresses this critical gap with a cherry-flavoured formulation that dissolves easily in breast milk or water, making it easier to administer while ensuring accurate dosing.
The approval was granted through Swissmedic’s fast-track procedure under the Marketing Authorization for Global Health Products (MAGHP) program. This mechanism allows for accelerated approvals of medicines intended for low-income and malaria-endemic countries, in partnership with the World Health Organization (WHO). This is only the third time the MAGHP route has been used by the Swiss regulator. The approval is expected to pave the way for registrations in malaria-endemic African countries, with at least eight nations already involved in joint review processes.
Malaria remains one of the world’s deadliest diseases, especially for children under five. In 2023, over 597,000 deaths were attributed to malaria globally—95% of them in Africa. While it was previously believed that newborns were protected through maternal immunity, emerging data now shows that infants in the first few months of life are highly susceptible to malaria and may suffer from severe outcomes, even with low parasite loads.
Medical experts have hailed this development as a major breakthrough. Coartem Baby, by offering a targeted, safe, and easy-to-administer treatment, could significantly reduce infant mortality rates due to malaria. Pediatric health specialists have emphasized that transparency in pricing, equitable distribution, and long-term accessibility must now follow this regulatory milestone to ensure the drug reaches those who need it most.
Novartis has announced that Coartem Baby will be distributed under a not-for-profit model in malaria-endemic regions, reinforcing the company’s commitment to global health equity. With global funding for malaria plateauing and rising concerns about drug resistance, the introduction of this new formulation comes at a crucial time in global public health.
The approval of Coartem Baby represents more than just the launch of a new drug. It marks a shift in how global health stakeholders, including pharmaceutical companies, regulators, and non-profit organisations, are beginning to prioritize vulnerable populations like newborns—who have historically been left out of pharmaceutical innovation.
Swissmedic’s nod is expected to serve as a regulatory blueprint for other countries. Within the next three months, nations involved in the WHO’s collaborative registration initiative are likely to begin rolling out national approvals. This will enable wider access to the drug in regions with the highest burden of paediatric malaria.
For the first time, infants—who make up a large portion of malaria-related deaths—will have access to a medicine specifically designed for their age and weight group. It is a milestone for pediatric care and a significant step forward in global efforts to eradicate malaria.
Photo Credit: The Hindu
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