08 July 2025
Category: Drug Approvals & Regulatory Updates I
Infectious Diseases – Malaria & Public Health Impact
Written By: Pharmacally Medical News Desk
In a landmark decision on July 8, 2025, Swissmedic approved Coartem® Baby (artemether-lumefantrine), also known as Riamet Baby in some countries, marking the world’s first antimalarial drug specifically formulated for infants weighing under 5 kg. This approval fills a long-standing gap in pediatric malaria care, as no evidence-based treatment regimen previously existed for this highly vulnerable population. The original Coartem formulation received its first approval in 1999; this new infant-specific dosage strength represents a major advancement in modifying malaria treatment to the needs of the youngest patients.
The CALINA Phase II/III Trial
The approval of this new formulation is based on clinical trial data conducted in babies weighing less than 5 kg. The CALINA study evaluated a novel fraction and dosage of Coartem baby (artemether-lumefantrine) in consideration of metabolic differences in infants weighing less than 5 kg.
CALINA (Clinical trial no. NCT04300309), the open-label, single-arm, multicountry Phase II/III study, enrolled infants weighing 2 kg to <5 kg with confirmed uncomplicated Plasmodium falciparum malaria. The trial divided subjects into age-based cohorts: neonates (<28 days) and young infants (up to 1 year).
Participants received a new artemether‑lumefantrine ratio (5 mg/60 mg) designed specifically for infants. The regimen included a core 43-day treatment and follow‑up, along with a 12‑month neurodevelopmental assessment, ensuring both safety and developmental well-being.
The trial sites cover six malaria-endemic nations: Burkina Faso, DRC, Kenya, Mali, Nigeria, and Zambia, coordinated by Novartis, Medicines for Malaria Venture (MMV), and Swiss TPH under the European & Developing Countries Clinical Trials Partnership (EDCTP2) funded PAMAfrica consortium.
The CALINA study showed that the infant-friendly dosage achieved target pharmacokinetic levels, with first-rate safety and tolerability. Cure rates imitated those seen in older children, with no new safety concerns reported. This result represents the first evidence-based dosing regimen tailored for infants under 5 kg.
Rollout under the MAGHP framework on a not-for-profit basis
The Swiss medic’s approval follows the results of the CALINA trial and the involvement of eight African regulators, who will benefit from expedited access via Switzerland’s Marketing Authorisation for Global Health Products (MAGHP) framework. This regulatory model supports rapid multi-country rollouts across malaria‑endemic regions.
Novartis promises to distribute Coartem® Baby on a not‑for‑profit basis, under a global health mandate with MAGHP coverage, ensuring no financial barrier for the most at‑risk infants.
Malaria Burden and Treatment Gap
Malaria remains a major public health threat worldwide, with around 600,000 deaths annually, with the highest burden seen in African countries and African children. Even though significant progress has been made in malaria treatment over the past few decades, very limited data are present for babies who are the most vulnerable group, weighing less than 5 kg.
Newborns can develop malaria through placental transmission before birth or by being bitten by infected mosquitoes after birth.
Currently, no malaria treatments are specifically designed or approved for infants under 5 kg. Instead, healthcare providers often use medications intended for older children, adjusting the dose by weight. This approach is risky because infants have immature liver and kidney function, which affects how their bodies process medications. As a result, they are more prone to drug-related side effects such as overdosing or toxicity.
Global Health Collaboration
The approval of Coartem® Baby is the result of a high-impact global collaboration among leading health and research organizations. Novartis played a central role by leveraging its pharmaceutical manufacturing and regulatory expertise to bring this pediatric formulation to life. The Medicines for Malaria Venture (MMV), a longstanding partner in antimalarial development, co-developed and funded the project alongside Novartis. The Swiss Tropical and Public Health Institute (Swiss TPH) led clinical investigations on the ground in the Democratic Republic of Congo (DRC), ensuring high-quality data collection and patient monitoring. Funding support also came from EDCTP2 through the PAMAfrica Consortium, which fostered strong Africa-Europe cooperation and helped fast-track the trial.
Final Take
Coartem® Baby, backed by robust CALINA data, has secured a world-first approval for neonatal antimalarial care, setting a new standard in pediatric care. By offering the medicine at no profit and working closely with regulators, specifically with countries that are facing the most burden of the disease, this treatment meets a significant requirement and shows how focused clinical trials can improve access to care for the most vulnerable population. As the rollout progresses through African nations, this could transform infant malaria treatment and save many beautiful souls.
References
Novartis receives approval for first malaria medicine for newborn babies and young infants, July 08 2025, Novartis, https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (CALINA), ClinicalTrials.gov ID NCT04300309, https://clinicaltrials.gov/study/NCT04300309
Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria, Novartis, 24 April 2024, https://www.novartis.com/news/media-releases/novartis-and-medicines-malaria-venture-announce-positive-efficacy-and-safety-data-novel-treatment-babies
Marketing Authorisation for Global Health Products (MAGHP), swissmedic, file:///C:/Users/admin/Downloads/Swissmedic_MAGHP_Procedure.pdf
Novartis wins approval for first malaria drug for newborns and babies, July 08 2025, https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-gets-approval-first-malaria-drug-babies-children-2025-07-08/
Malaria, World Health Organization (WHO), https://www.who.int/news-room/fact-sheets/detail/malaria
Liu Q, Zhang S, Wu Y, Global, regional and national burden and time trends of malaria in children and young adolescents under 15 years from 1990 to 2021: a worldwide observational study. BMC Infect Dis. 2025 Apr 17; 25(1):548. Doi: 10.1186/s12879-025-10949-9. PMID: 40247186; PMCID: PMC12004559.
Malaria, Nearly every minute, a child under 5 dies of malaria, UNICEF for every child, https://data.unicef.org/topic/child-health/malaria/
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