BASEL, Switzerland, April 24, 2026

Novartis has achieved a major global health milestone as the World Health Organization (WHO) granted prequalification to Coartem® Baby (artemether-lumefantrine), the first and only antimalarial therapy specifically developed for newborns and young infants weighing 2 to 5 kilograms. This landmark decision paves the way for broad access through United Nations and global public health procurement programs, addressing a long-standing treatment gap in one of the world’s most vulnerable patient populations. The therapy, developed in collaboration with Medicines for Malaria Venture, represents a critical advancement in pediatric infectious disease care, particularly in malaria-endemic regions where infant mortality remains high.

First Targeted Treatment for Vulnerable Infant Population

Coartem® Baby is the first antimalarial medicine specifically designed for newborns and infants under 5 kilograms, a group historically underserved due to the lack of appropriately formulated treatments. Until now, clinicians have often relied on adapted dosing of therapies intended for older children, increasing the risk of toxicity and suboptimal efficacy.

This new formulation provides a safe, effective, and tailored therapeutic option, significantly improving treatment outcomes for infants diagnosed with uncomplicated malaria. According to global health data, malaria remains a life-threatening disease with over 280 million cases and more than 600,000 deaths annually, with children under five accounting for the majority of fatalities, particularly in Africa. By addressing this critical gap, Coartem® Baby is expected to reduce mortality rates and improve early-life health outcomes in high-risk populations.

WHO Prequalification Enables Global Access

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The WHO prequalification is a key regulatory milestone that validates the quality, safety, and efficacy of Coartem® Baby, enabling procurement by UN agencies and global health organizations. This designation is essential for facilitating donor-funded distribution programs, ensuring that the treatment can reach low- and middle-income countries where malaria burden is highest.

Novartis has committed to making the therapy available on a largely not-for-profit basis in endemic regions, reinforcing its dedication to equitable healthcare access and global disease control efforts. The product has already been introduced in countries such as Ghana, with plans to expand availability across additional regions through strategic partnerships and public health initiatives. This collaborative approach highlights the importance of multi-stakeholder engagement in addressing global health challenges.

Advancing Malaria Innovation and Global Health Impact

The development of Coartem® Baby builds on Novartis’ long-standing commitment to malaria innovation, including the delivery of over 1.1 billion treatment courses of Coartem since 1999. The company continues to invest heavily in next-generation antimalarial therapies, with a pipeline that includes new compounds designed to combat drug resistance and improve treatment outcomes.

This latest achievement underscores the growing role of targeted pediatric therapies in infectious disease management, as well as the importance of innovation tailored to vulnerable populations. Experts believe that Coartem® Baby could play a transformative role in reducing infant mortality and closing critical treatment gaps, marking a significant step forward in the global fight against malaria. As efforts to eliminate malaria intensify, innovations like this are expected to drive meaningful progress toward improved public health outcomes worldwide.

Source: Novartis press release