In a global first, Novartis and the Medicines for Malaria Venture (MMV) have received regulatory approval for Coartem Baby, an antimalarial medication specifically designed for infants weighing 2–5 kg (4.4–11 lbs). Approved by Swissmedic under the Marketing Authorization for Global Health Products (MAGHP) framework, this decision paves the way for fast-tracked approvals in eight malaria-endemic African countries, including Kenya, Nigeria, Uganda, and Mozambique.
Coartem Baby is a reformulated version of Coartem (also marketed as Riamet), first introduced in 1999 and later approved by the FDA in 2009. It combines artemether and lumefantrine, a trusted antimalarial duo, in a baby-friendly cherry-flavored, dissolvable formulation that can be administered with breast milk. The approval followed Phase 2/3 clinical trials tailored to infants under 5 kg, accounting for their unique metabolic profiles.
“We’ve stayed the course in the fight against malaria, bringing innovation where it’s most needed,” said Vas Narasimhan, CEO of Novartis.
Addressing a Critical Gap in Infant Malaria Treatment
Infants younger than six months—one of the most vulnerable populations—have long been excluded from malaria clinical trials due to underdeveloped liver function and unpredictable drug metabolism. As a result, no approved antimalarial treatment had existed for this group—until now.
Malaria continues to be one of the deadliest diseases in the world, with 597,000 deaths in 2023, according to the World Health Organization (WHO). An alarming 76% of those deaths were among children under five, most of them in Africa. Coartem Baby’s approval is a major step toward reducing that toll.
Even as other pharmaceutical giants scale back investment in Neglected Tropical Diseases (NTDs), Novartis has doubled its R&D commitment, advancing 10 new therapies and currently running a Phase 3 trial for a next-generation malaria drug. The company is also researching treatments for dengue, Chagas disease, leishmaniasis, and cryptosporidiosis.
“Malaria can be beaten with the right investments and attention,” said Martin Fitchet, CEO of MMV. “Coartem Baby is a much-needed addition that could help save thousands of young lives.”
Novartis Makes History with First Malaria Drug Approved for Infants
Novartis has achieved a groundbreaking milestone in global health by becoming the first company to receive regulatory approval for a malaria drug specifically designed for infants. This historic achievement marks a major step forward in the fight against one of the world’s deadliest infectious diseases.
The newly approved treatment, developed by Novartis, targets malaria in children under two years old — the group most vulnerable to severe infection and death. The company’s innovation is expected to transform malaria prevention and treatment strategies across Africa and other high-risk regions.
According to Novartis, the drug went through years of rigorous clinical testing to ensure safety and efficacy for young patients. This new medication represents not only scientific progress but also a humanitarian triumph, reinforcing Novartis’s commitment to global health equity.
Experts believe this approval could encourage more pharmaceutical investment in pediatric treatments for neglected tropical diseases. With this success, Novartis continues to lead in medical innovation, expanding access to life-saving therapies for communities that need them most.
Novartis has made history by securing the world’s first approval for a malaria drug designed specifically for infants, a major advancement in the global fight against malaria. This breakthrough highlights Novartis’s long-standing commitment to addressing unmet medical needs and improving child health outcomes in developing countries.
The newly approved treatment aims to protect children under the age of two — a group that accounts for the majority of malaria-related deaths each year. Novartis conducted years of extensive research and clinical trials to ensure the drug’s safety, efficacy, and ease of use in infants.
Health experts have praised Novartis for prioritizing innovation in global health, noting that this drug could significantly reduce infant mortality in malaria-endemic regions. The company has announced partnerships with African health ministries and global organizations to ensure equitable access and affordable pricing for the new medication.
