Newborn and infant malaria treatment drug on the brink of Africa approval within weeks
The Swiss pharmaceutical corporation, Novartis, has announced the approval of Coartem Baby, a malaria treatment specifically designed for newborns and young infants weighing less than 4.5 kg, by Swissmedic. This approval marks a significant step forward in the global fight against malaria, particularly in Africa, where the disease remains one of the deadliest for children.
Martin Fitchet, chief executive of the Medicines for Malaria Venture (MMV), emphasised the importance of this development, stating that malaria is one of the world's deadliest diseases, particularly among children. He added that the approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients.
Until now, the smallest babies have been treated for malaria with medications designed for older children, which can expose newborns to the risk of overdose and toxicity. Coartem Baby, however, is formulated to be easy for infants to take.
Novartis plans to roll out Coartem Baby in the coming weeks on a largely not-for-profit basis. Eight African countries, including Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, are expected to grant their own approvals for Coartem Baby within 90 days, paving the way for its rapid adoption across the continent.
The World Health Organization reported that in 2023, there were 263 million cases of malaria and 597,000 deaths. Nearly all malaria deaths in 2023 occurred in Africa, with children under the age of 5 accounting for about three in four malaria deaths in Africa. Fitchet added that with the right resources and focus, malaria can be eliminated.
This development represents a major milestone in malaria treatment, especially for the most vulnerable populations in Africa. Coartem Baby, also known as Riamet Baby, is the first clinically proven malaria treatment for newborns and young babies. Its approval ensures that even the smallest and most vulnerable can finally receive the care they deserve.
References: [1] Novartis (2025). Novartis' Coartem Baby approved in Switzerland for infants weighing 2-5 kg. Retrieved from https://www.novartis.com/news/media-releases/novartis-coartem-baby-approved-switzerland-infants-weighing-2-5-kg
[2] Medicines for Malaria Venture (2025). Coartem Baby approved in Switzerland for infants weighing 2-5 kg. Retrieved from https://www.mmv.org/news/coartem-baby-approved-switzerland-infants-weighing-2-5-kg/
[3] World Health Organization (2023). Malaria Fact Sheet. Retrieved from https://www.who.int/news-room/fact-sheets/detail/malaria
[4] World Malaria Report (2024). World Malaria Report 2024. Retrieved from https://www.who.int/publications/i/item/9789240037476
[5] Swissmedic (2025). Approval of Coartem Baby for infants weighing 2-5 kg. Retrieved from https://www.swissmedic.ch/en/home/approval/new-medicines/coartem-baby-for-infants-weighing-2-5-kg/
- The approval of Coartem Baby by Swissmedic signifies progress in the fight against health-and-wellness issues like malaria.
- This development is significantly essential, especially in regions where malaria is one of the deadliest diseases, such as Africa.
- Martin Fitchet, CEO of Medicines for Malaria Venture (MMV), has underlined the importance of this development.
- Fitchet noted that the approval of Coartem Baby offers a necessary medicine tailored to treat an often neglected demographic.
- The previous treatments for malaria in the tiniest babies were medications originally designed for older children.
- Such drugs put newborns at risk of overdose and toxicity due to their smaller size.
- Coartem Baby, however, is specifically formulated to be easy for infants to ingest.
- Novartis plans to start distributing Coartem Baby in the following weeks on a not-for-profit basis.
- Eight African countries are expected to follow Switzerland's approval within 90 days.
- These countries include Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda.
- The World Health Organization reported 263 million cases of malaria and 597,000 deaths in 2023.
- Nearly all malaria deaths in 2023 occurred in Africa, with children under the age of 5 accounting for about three in four malaria deaths in Africa.
- Fitchet believes that with the proper resources and focus, malaria can be eradicated.
- This development is a major milestone in malaria treatment, particularly for the most vulnerable populations in Africa.
- Coartem Baby is the first clinically proven malaria treatment for newborns and young babies.
- This approval guarantees that even the smallest and most vulnerable can finally receive the healthcare they require.
- Malaria is a significant global health problem that affects millions annually, disproportionately impacting the healthcare and wellness of children.
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