Novartis wins approval: First malaria treatment drug for newborns and babies is here
Until now, there have been no approved malaria drugs specifically for babies. Instead, they have been treated with versions formulated for older children, which presents a risk of overdose. This cherry‑flavored, breast‑milk–compatible, dispersible tablet closes a dangerous treatment gap for infants under 4.5 kg, who previously relied on doses designed for older children – raising overdose risks.
Developed in collaboration with Medicines for Malaria Venture and backed by robust Phase 2/3 data, this new therapy is poised for rapid roll‑out across Africa.
It's an inflection point in global health and malaria control.
Critical treatment gap addressed
Malaria remains one of the most devastating diseases in sub‑Saharan Africa, with nearly 263 million cases and roughly 600,000 deaths in 2023. Shockingly, infants under five account for three‑quarters of these deaths. Until now, infants weighing less than 4.5 kg – roughly 10 lb – had no approved therapy. They were administered antimalarial tablets formulated for older children, a practice fraught with dosing errors and toxicity risks.
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Coartem Baby fills this critical void, offering a dosage specifically tailored to newborn metabolism and weight.
Infant-centric design and administration
This pediatric formulation includes artemether-lumefantrine, the proven gold-standard antimalarial adopted globally since 1999. Coartem Baby is not just the first of its kind – it's built for infants' realities. It's the new infant‑friendly features that matter most:
Sweet cherry-flavored, dispersible tablet that dissolves
in water or breast milk, making it easy and palatable to administer in low-resource settings.
Optimized dosing based on metabolic differences in neonates:
the lower dose ratio (artemether-lumefantrine) addresses immature liver function (low dose for infants 2–5 kg).
Clean and safe delivery ensures compliance
– no crushed pills or makeshift dosing methods.
These characteristics simplify administration in low‑resource settings, proving much more effective than crushed or adapted pediatric tablets, especially for caregivers who face limited infrastructure and training.
Backed by clinical evidence
The drug's effectiveness is rooted in strong Phase II/III clinical trials, collectively known as CALINA, conducted across multiple African countries, including Burkina Faso, Kenya, Nigeria, Mali, Zambia, the DRC, and more. These trials confirmed dosing safety and efficacy in infants under 5 kg, accounting for their unique pharmacokinetics due to immature liver function. As Professor Umberto D'Alessandro from the London School of Hygiene & Tropical Medicine explains, infants metabolize drugs differently, making tailored formulations essential.
A fast‑track global roll‑out
Swissmedic's approval, granted under its Marketing Authorization for Global Health Products scheme, also engages eight malaria-endemic African countries – Burkina Faso, Côte d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda. These nations can now fast‑track local approval within 90 days, paving the way for widespread pediatric access.
Access and equity: The 'Not‑for‑profit' ethos
Novartis, with the support of Medicines for Malaria Venture (MMV), plans to distribute Coartem Baby largely on a not-for-profit basis, aligning with its long-standing commitment, having provided over 1.1 billion malaria treatments since 1999.
Co-funded by health agencies like EDCTP and SIDA, and built in partnership with PAMAfrica, the rollout is structured to democratize access across Africa.
The broader context
This release comes amid alarming trends: reductions in malaria aid funding, expanding mosquito ranges due to climate change, and rising drug resistance. While vaccines like RTS,S are only approved for older infants (≈5+ months), Coartem Baby fills a critical early-life gap.
As Dr. Bhargavi Rao from LSHTM notes, 'Even very low levels of parasites can give…severe malaria and death' in neonates.
Looking ahead
The approval of Coartem Baby is more than a pharmaceutical milestone – it is a public‑health triumph. By delivering a scientifically crafted solution for the tiniest malaria patients, Novartis and MMV are not only saving lives but also redefining equitable healthcare delivery. However, some challenges remain. Ensuring transparent pricing, resilient supply chains, and community education is paramount. Continued monitoring of drug resistance and scale-up of complementary tools – like insecticide‑treated nets and vaccines – will be critical.
Encouragingly, Novartis continues to invest in cutting‑edge antimalarials (e.g., ganaplacide) and downstream pediatric formulations.
USFDA allows emergency use of drug for coronavirus
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