World Health Organization has prequalified Coartem Baby (artemether-lumefantrine) as the first-ever malaria treatment specifically designed for newborns and young infants. The drug has been developed by Novartis in collaboration with Medicines for Malaria Venture.
This milestone addresses a long-standing treatment gap in malaria care for very low-weight infants, marking a significant advancement in global public health.
Key Features of Coartem Baby
- The treatment is specifically designed for infants weighing between 2 kg and 5 kg, a group previously lacking appropriate formulations.
- It is formulated as a child-friendly dissolvable tablet, which can be easily mixed with breast milk, ensuring safe administration.
- The tablet has a sweet cherry flavour, improving acceptability and ease of use for caregivers.
- The drug will be supplied by Novartis on a largely not-for-profit basis in malaria-endemic regions, as per WHO guidance.
Why This is a Breakthrough
- Earlier, infants under 5 kg were treated using crushed adult or older-child tablets, which often led to: Dosing errors and Increased risk of toxicity and side effects
- The new formulation is scientifically optimized for infants, considering: Immature liver function and Unique metabolic requirements
- The WHO prequalification acts as a global quality assurance mechanism, enabling:
- Procurement by UN agencies
- Large-scale international distribution
Scientific Basis: CALINA Study
The approval is based on the CALINA Study, a Phase II/III clinical trial that determined the appropriate dosage and ratio of artemether-lumefantrine for infants under 5 kg.
- The treatment has already been introduced in Ghana.
- Wider rollout across African countries is expected within weeks, particularly in malaria-endemic regions.
WHO Prequalifies New Rapid Diagnostic Tests (RDTs)
Alongside the new treatment, WHO prequalified three new rapid diagnostic tests (RDTs) on April 14, 2026 to detect “invisible” malaria strains, particularly of Plasmodium falciparum, that conventional tests fail to identify.
Problem with Existing Tests
- Standard malaria tests detect the HRP2 (Histidine-Rich Protein 2) protein.
- In several regions (nespecially Horn of Africa), Plasmodium falciparum has undergone gene deletion, meaning:
- HRP2 is not produced
- Tests return false negatives despite infection
- In some areas, up to 80% of cases were missed due to this limitation.
New BIOCREDIT Diagnostic Tests
The newly approved tests (manufactured by Rapigen Inc.) target pLDH (Parasite Lactate Dehydrogenase), an essential enzyme that the parasite cannot easily eliminate.
Types of Tests
- BIOCREDIT Malaria Ag Pf (pLDH): Detects P. falciparum even when HRP2 is absent
- BIOCREDIT Malaria Ag Pf (pLDH/HRP2): Dual-target test for higher reliability in mixed transmission zones
- BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH): Differentiates between P. falciparum and P. vivax without relying on HRP2
Working Mechanism
- These tests detect pLDH enzyme, which is critical for parasite survival and cannot be easily suppressed.
- This overcomes the “invisibility” problem caused by HRP2 gene deletions.
- WHO recommends countries adopt these tests when ≥5% of malaria cases show HRP2 gene deletion.
About Malaria
- Malaria is a life-threatening vector-borne disease transmitted by infected female Anopheles mosquitoes.
- It is caused by Plasmodium parasites, mainly:
- Plasmodium falciparum (most severe)
- Plasmodium vivax
- Transmission occurs through mosquito bites, and rarely through blood transfusion or contaminated needles.
Symptoms
- Fever, headache, chills (often within 10–15 days)
- Severe cases may lead to organ failure and death, especially if untreated within 24 hours
High-Risk Groups
- Infants and children under 5
- Pregnant women
- Travellers and immunocompromised individuals
India’s Progress in Malaria Elimination
- At independence (1947), India recorded 7.5 crore cases and 8 lakh deaths annually.
- India has made significant progress through targeted interventions and strong political commitment.
- In 2024, India exited the WHO’s High Burden to High Impact (HBHI) group.
- Supported by:
- National Framework for Malaria Elimination (2016–2030)
- National Strategic Plan (2023–2027)
Achievements
- 80.5% reduction in cases and 78.3% reduction in deaths (2015–2023)
- Over 122 districts reported zero cases
- Target:
- Zero indigenous cases by 2027
- Complete elimination by 2030
Significance
- Bridges a critical treatment gap for newborns and low-weight infants, reducing mortality risk.
- Enhances diagnostic accuracy, especially in regions with evolving parasite resistance.
- Strengthens global malaria control strategies by combining treatment innovation with improved detection tools.
- Supports large-scale deployment through WHO’s prequalification framework, ensuring accessibility in endemic regions.