Novartis Coartem Baby Receives WHO Prequalification as First Malaria Treatment for Newborns

Key Takeaways

• Coartem Baby becomes the first and only WHO-prequalified malaria treatment specifically for newborns and young infants
• WHO prequalification enables UN agencies and donors to procure the treatment for public health programs globally
• Novartis will provide the treatment on a largely not-for-profit basis in malaria-endemic regions

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Novartis announced April 24, 2026, that the World Health Organization (WHO) has prequalified Coartem Baby (artemether-lumefantrine), marking a breakthrough as the first malaria treatment specifically approved for newborns and young infants.

The WHO prequalification represents a critical milestone that closes a long-standing treatment gap for the most vulnerable malaria patients. Previously, no approved malaria treatments existed specifically formulated for newborns and young infants, leaving healthcare providers with limited options for this high-risk population.

Enabling Global Access Through WHO Prequalification

WHO prequalification serves as a quality assurance mechanism that enables UN agencies, including UNICEF and the Global Fund, along with other international procurement organizations to purchase medicines for donor-funded public health programs. This designation is particularly crucial for treatments targeting diseases prevalent in low- and middle-income countries.

The prequalification process involves rigorous evaluation of manufacturing quality, safety, and efficacy data to ensure medicines meet international standards. For Coartem Baby, this approval validates the treatment’s safety profile and effectiveness in treating malaria in the youngest patients.

Market Impact and Access Strategy

Novartis has committed to making Coartem Baby available on a largely not-for-profit basis in areas where malaria is endemic. This pricing strategy aligns with global health initiatives aimed at reducing malaria mortality, particularly among children under five who account for the majority of malaria deaths worldwide.

The treatment addresses a critical unmet medical need, as newborns and young infants face the highest risk of severe malaria complications and death. According to WHO data, malaria killed approximately 608,000 people in 2022, with children under five representing about 76% of all deaths.

Next Steps for Implementation

With WHO prequalification secured, procurement agencies can now include Coartem Baby in their treatment protocols and purchasing decisions. The availability of this specialized formulation is expected to improve treatment outcomes and reduce mortality rates among the youngest malaria patients in endemic regions.

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Frequently Asked Questions

What makes Coartem Baby different from existing malaria treatments?

Coartem Baby is specifically formulated for newborns and young infants, addressing a critical treatment gap as no other approved malaria treatments existed for this vulnerable age group.

When will Coartem Baby be available to patients?

With WHO prequalification now secured, UN agencies and procurement organizations can begin purchasing Coartem Baby for public health programs, though specific availability timelines will depend on individual country procurement processes.

How will pricing work for Coartem Baby?

Novartis will provide Coartem Baby on a largely not-for-profit basis in malaria-endemic areas, making it accessible for donor-funded programs and public sector purchasing in regions where malaria is prevalent.