Daijiworld Media Network – Geneva

Geneva, Jul 9: In a major breakthrough in the fight against malaria, Swissmedic, Switzerland’s medical products authority, has granted the first-ever approval for a malaria drug specifically formulated for small infants. The new medication, Coartem Baby, developed by Basel-based Novartis, is intended for babies weighing between 2 and 5 kilograms and is seen as a significant step toward protecting the youngest and most vulnerable from the mosquito-borne illness.

Approved under a fast-track procedure coordinated with the World Health Organization (WHO), Coartem Baby is a lower-dose version of an existing antimalarial combination used in older children. It marks only the third time Swissmedic has granted fast-track approval aimed at helping developing nations access critical medicines.

"This is a drug which we know is safe, we know works well, and therefore it will just be available as a new version for a specific age group," said Dr Quique Bassat, a malaria expert and director-general of the Barcelona Institute for Global Health (ISGlobal). He emphasized the importance of proper dosing in very young children, who until now received adapted doses of adult medicines—a method he called ‘suboptimal.’

Novartis confirmed that eight African countries were involved in the regulatory assessment and are expected to approve the drug within the next 90 days. The company plans to distribute the medicine on a ‘largely not-for-profit basis’ in malaria-endemic nations.

Despite advancements like new vaccines and mosquito control programs, malaria cases are rising, particularly in crisis-hit regions. Dr Bhargavi Rao from the London School of Hygiene and Tropical Medicine stressed the need for equitable access and pricing transparency for the new medication.

“It is significant to finally have a suitable and safe treatment for very young children more than 20 years since WHO first pre-qualified Coartem for older age groups,” she noted.

In 2023, malaria claimed an estimated 597,000 lives globally, with Africa accounting for 95% of those deaths. More than three-quarters of the victims were children. Experts hope the approval and rollout of Coartem Baby will save countless lives and close a critical treatment gap.