Today, Swissmedic approved the first malaria medicine for newborn babies and young infants under 4.5 kg. The decision is expected to accelerate regulatory approvals in eight African countries. The approval is based on data from the multicountry CALINA clinical trial, in which Swiss TPH played a key operational and scientific role, including site management, monitoring and molecular analysis.
Swiss TPH contributed to the development of the new drug through clinical operations and trial site management in the DRC (Photo: Fairpicture/Swiss TPH)
Young infants have long been excluded from malaria treatment innovation due to a lack of age-appropriate formulations. Today, Swissmedic has approved Coartem® Baby (also known as Riamet® Baby), the first malaria treatment specifically developed for newborns and young infants weighing under 4.5 kg. The new drug, developed under a public-private partnership led by Novartis and Medicines for Malaria Venture (MMV) is dissolvable, including in breast milk, and has a sweet cherry flavour to facilitate administration.
Approval paves way for authorisation in African countries
The approval, granted under Swissmedic’s Marketing Authorisation for Global Health Products (MAGHP) pathway, paves the way for accelerated authorisations across eight African countries: Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda. This milestone approval is based on data from the phase II/III CALINA trial, which evaluated the efficacy and safety of artemether-lumefantrine in infants weighing less than 5 kg.
“Neonates have long been overlooked in malaria treatment. This approval marks a crucial step towards equitable care — and shows what’s possible through strong public–private partnerships,” said Elisabeth Reus, Head of the Clinical Operations unit at Swiss TPH.
Public–private partnership
The new dose strength designed for young infants was developed by Novartis with the scientific and financial support of MMV, and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Swedish International Development Cooperation Agency.
Swiss TPH contributed to the CALINA trial through clinical operations and trial site management in the Democratic Republic of the Congo (DRC), one of several countries involved in the study. Between 2020 and 2023, the DRC site screened over 14,000 infants with suspected malaria, ultimately enrolling 21 infants under 5 kg. The site achieved the highest recruitment numbers in the study. Swiss TPH also conducted the molecular analyses for all study sites involved in the CALINA trial.
Clinical trial expertise in challenging settings
Swiss TPH has over 20 years of experience in designing, implementing and managing clinical trials across low-resource settings, with a focus on diseases that disproportionately affect low- and middle-income countries, neglected populations and paediatric population. Swiss TPH supports phase I to phase IV studies both as a sponsor and as a service provider.
