Novartis Gains First-ever Approval for Infant Malaria Medicine
In a breakthrough for pediatric malaria treatment, Novartis has received approval from Swissmedic for Coartem® (artemether-lumefantrine) Baby, marking the first-ever approved malaria medicine specifically for newborn babies and young infants. This pediatric formulation, also known as Riamet® Baby in some countries, was developed in partnership with Medicines for Malaria Venture (MMV).
The milestone approval was issued under Swissmedic’s Marketing Authorization for Global Health Products (MAGHP) procedure, a collaborative regulatory pathway aimed at accelerating access to critical medicines in low- and middle-income countries. Participating in the MAGHP process were eight African nations, which are now expected to grant rapid local approvals. Novartis intends to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in malaria-endemic regions.
Bridging a Critical Malaria Treatment Gap for Infants
Until now, no malaria treatment had been approved for infants under 4.5 kg, leaving healthcare providers to rely on formulations designed for older children, raising risks of dosing errors and toxicity. With approximately 30 million babies born each year in malaria-endemic regions of Africa, the need for an age- and weight-appropriate treatment has been urgent.
Vas Narasimhan, CEO of Novartis, stated:
“For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most. Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.
Infant-Friendly, Scientifically Tailored Formulation
The newly approved formulation is designed to address the unique physiological needs of newborns and young infants, including their immature liver function and differing drug metabolism. The dissolvable cherry-flavored treatment can be administered with breast milk, making it easier for caregivers to deliver full courses of therapy.
Professor Umberto D’Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine, said:
“The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials. That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.”
Backed by Clinical Evidence from the Phase II/III CALINA Study
Swissmedic’s approval was based on the results of the Phase II/III CALINA study, which evaluated a modified ratio and dose of Coartem® (artemether-lumefantrine) to accommodate infants weighing between 2 and less than 5 kilograms. The treatment is indicated for acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum. Coartem® is known by the brand name Riamet® in Switzerland and some other countries.
Global Partnerships Driving Access and Affordability
The development of Coartem Baby was part of the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency, with additional scientific and financial support from MMV.
Martin Fitchet, CEO of MMV, commented:
“Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated. The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.”
A Persistent Global Threat
According to World Health Organization (WHO) data, malaria caused 263 million cases and 597,000 deaths in 2023, with the vast majority occurring in Africa. Children under five accounted for approximately 75% of those deaths. Despite vaccines becoming available for older children, no malaria vaccines are currently approved for infants under six months.
Commitment to Innovation in Malaria and Neglected Diseases
Novartis continues to invest heavily in malaria R&D, with USD 490 million in global health funding since 2021. The company boasts the industry’s largest pipeline for malaria and neglected tropical diseases, including four investigational antimalarial compounds to combat emerging resistance. One candidate is nearing completion of Phase III trials, while another has the potential to offer a single-dose cure.
Since launching Coartem in 1999, Novartis has delivered over 1.1 billion treatment courses globally, including 500 million doses of child-friendly formulations.
As Coartem® (artemether-lumefantrine) Baby prepares for its broader rollout, the pharmaceutical industry watches closely, with the hope that this long-awaited treatment marks a turning point in protecting the youngest lives from one of the world’s most persistent killers.
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