A Landmark in Global Health: First Malaria Drug Approved for Newborns
9 July 2025
In a major breakthrough for pediatric infectious disease treatment, Novartis has announced the world’s first approved malaria treatment specifically formulated for newborns. The new therapy, Coartem® Baby, addresses a long-standing treatment gap for infants weighing between 2 and 5 kilograms, a vulnerable population previously treated using formulations designed for older children.
The dispersible, cherry-flavored formulation can dissolve in liquids, including breast milk, making it easier and safer to administer in high-burden settings. Beyond its clinical importance, the approval also highlights the growing impact of public–private partnerships in addressing neglected global health challenges.
This article explores:
The significance of the first approved malaria treatment specifically designed for newborns and why this milestone matters for global child health.
The global burden of neonatal malaria and the treatment gap that existed for infants under 5kg.
How artemisinin-based therapies like Coartem® work at the molecular and parasite life-cycle level to treat and reduce malaria transmission.
The critical role nonprofit organizations such as Medicines for Malaria Venture (MMV) play in advancing innovation for neglected tropical diseases.
Why diseases like malaria continue to face chronic R&D underinvestment, and how equity-driven public–private partnerships can help overcome these market failures.
Developed Through Partnership
This innovation was made possible through the scientific and financial support of Medicines for Malaria Venture (MMV), a Swiss nonprofit that partners with the pharmaceutical sector to develop antimalarials for underserved populations. Clinical assessments of Coartem® Baby took place across eight African countries: Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda. These countries are now expected to authorize the treatment locally, where it may be marketed as Riamet® Baby.
This marks not only a medical milestone, but also a case study in effective public-private collaboration to address neglected global health needs.
Why Neonatal Malaria Matters
Despite ongoing progress in malaria control, the disease remains one of the deadliest infectious diseases globally. In 2022, there were an estimated 249 million malaria cases and 608,000 deaths, with 95% of deaths occurring in the WHO African Region(1).
Each year, around 30 million babies are born in malaria-endemic regions in Africa (2). These infants are particularly vulnerable because they are not currently eligible for malaria vaccination and, until now, have had no dedicated treatment formulation. A study conducted across West Africa reported malaria infection rates between 3.4% and 18.4% in infants younger than six months (3).
This approval is a significant step toward addressing this critical treatment gap.
How Coartem® Works: Mechanism of Action
Coartem® is a fixed-dose combination therapy containing artemether and lumefantrine, two potent antimalarial agents. Its effectiveness stems largely from artemisinin, a compound originally derived from the plant Artemisia annua, used in traditional Chinese medicine for centuries (4).
Artemisinin and its derivatives primarily target the erythrocytic (asexual blood) stage of the malaria parasite (Plasmodium falciparum), when it replicates within red blood cells. Specifically, these compounds disrupt the development of trophozoites and schizonts, preventing the release of new merozoites and thereby halting parasite proliferation (5).
The mechanism involves the cleavage of an endoperoxide bridge in artemisinin upon contact with ferrous iron (Fe²⁺), abundant in infected erythrocytes. This reaction generates reactive oxygen species (ROS), including oxygen and carbon-centered free radicals, which damage parasite proteins and membranes, ultimately leading to cell death (6).
Importantly, artemisinin also exhibits partial activity against early-stage gametocytes, the sexual forms of the parasite responsible for transmission to mosquitoes. While not curative for late-stage gametocytes, this feature gives artemisinin-based therapies a dual role in both treatment and transmission reduction (7).
The Role of Nonprofits in Driving Innovation
The development of Coartem® Baby illustrates the vital role of nonprofit organizations in areas where commercial incentives are limited. Neglected Tropical Diseases (NTDs) like malaria disproportionately affect populations in low-income countries, offering little return on investment for traditional pharmaceutical models (8).
Organizations like MMV bridge this gap by:
Funding early-stage research
Coordinating multinational clinical trials
Facilitating regulatory engagement in endemic countries
Supporting access and delivery in underserved populations
Without this infrastructure, novel pediatric formulations like Coartem® Baby might never reach the market.
Rethinking R&D for Neglected Diseases
Despite causing immense suffering and mortality, Neglected Tropical Diseases (NTDs) continue to be sidelined in the global R&D agenda. Diseases like malaria, leishmaniasis, Chagas disease, and others remain a major burden across the Global South, yet they attract only a fraction of the pharmaceutical industry's attention and investment.
Why? Simply put: NTDs are not profitable.
They disproportionately affect low-income populations in resource-limited settings, where the potential return on investment for pharmaceutical companies is minimal. As a result, many promising treatments never make it out of discovery, and existing therapies often remain outdated, inaccessible, or poorly suited to the needs of the most vulnerable, including children and infants.
This systemic underinvestment is not due to scientific barriers, but to economic disincentives. The consequences are stark: treatable diseases persist, patients suffer, and global health inequities deepen.
But there is hope and progress.
Thanks to targeted efforts by nonprofit organizations like MMV, and growing engagement from forward-looking industry partners like Novartis, this model is beginning to shift. Novartis, for example, has nearly doubled its R&D investment in NTDs, advancing 10 new candidates and expanding its pipeline to include dengue fever, cryptosporidiosis, and more (9). Crucially, these advances are often made possible by public-private partnerships that share risk, funding, and expertise.
“Millions of babies born in malaria-endemic regions each year deserve the best possible start in life. This new formulation is a powerful step forward in making sure no child is left behind.”
— Dr. David Reddy, CEO, Medicines for Malaria Venture (MMV)
This collaborative approach offers a roadmap for how equity-driven innovation can overcome market failures. The approval of Coartem® Baby is not just a medical achievement. It is evidence that when global health needs are prioritized over profits, real breakthroughs follow.
Conclusion
The approval of Coartem® Baby is more than a regulatory success. It is a life-saving intervention for some of the world’s most at-risk infants. It reflects what can be achieved when science, public health, and mission-driven organizations align.
As we move toward a malaria-free future, targeted innovations like this are essential. While challenges remain, this development marks a hopeful step forward in global malaria control and a reminder of what global health equity can look like when we invest in it.
References
World Health Organization. World Malaria Report 2023.
MMV. Every Baby Counts. MMV Official Website
Sarrassat, S., et al. (2020). Prevalence of malaria parasitemia among infants in West Africa. Malaria Journal, 19(1), 140.
Tu, Y. (2016). Artemisinin — A Gift from Traditional Chinese Medicine to the World (Nobel Lecture).Angewandte Chemie International Edition, 55, 10210–10226.
White, N. J. (2008). Qinghaosu (Artemisinin): The Price of Success.Science, 320(5874), 330–334.
Meshnick, S. R. (2002). Artemisinin: mechanisms of action, resistance and toxicity.International Journal for Parasitology, 32(13), 1655–1660.
Delves, M., et al. (2018). The biology and treatment of Plasmodium falciparum gametocytes.Trends in Parasitology, 34(5), 419–431.
Pedrique, B., et al. (2013). The drug and vaccine landscape for neglected diseases (2000–11).The Lancet Global Health, 1(6), e371–e379.
