The first malaria drug for newborn babies and those weighing less than 11 pounds has been approved by Swiss medical authorities in a move that could fill a treatment gap for some of those most vulnerable to the disease, developers and experts say.
Coartem Baby, also known as Riamet Baby, was developed by the Swiss nonprofit organization Medicines for Malaria Venture in collaboration with the Swiss drug company Novartis to treat the deadly mosquito-borne illness, MMV said in a statement Tuesday.
Despite being both preventable and treatable, malaria remains a serious global health threat, with 263 million cases and 597,000 deaths worldwide in 2023, according to the latest World Health Organization report. Children under 5 are some of the most vulnerable, accounting for about 76 percent of all malaria deaths in the WHO’s Africa region, according to 2023 figures.
“The newly authorised product addresses a critical treatment gap for one of the most vulnerable patient populations – young infants suffering from malaria,” Switzerland’s health regulator, Swissmedic, said in a statement Tuesday. It said the development of a formulation especially for children marked a “significant step forward in the global fight against malaria.”
Coartem contains a combination of antimalarial drugs artemether and lumefantrine, which is already approved for use in patients weighing more than 11 pounds. However there had been no approved treatment for babies weighing less than this. Most birth weights are between 5.2 pounds and 9.7 pounds, according to WHO global figures.
Now, the drug has been approved for those weighing between 4.4 and 11 pounds by Swissmedic, under its Marketing Authorization for Global Health Products (MAGHP), which is focused on developing treatments for diseases that affect sub-Saharan Africa.
The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer, MMV said in its statement.
The drug has been authorized in collaboration with national regulatory authorities in eight African countries: Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Uganda, and Tanzania, Swissmedic said. Individual countries are expected to approve use of the treatment within 90 days after it is submitted for regulatory approval, to help ensure timely access to the drug.
Bhargavi Rao, the co-director of the Malaria Center at the London School of Hygiene and Tropical Medicine, who was not involved in the research, said the new treatment is a welcome development for both very young babies and malnourished children who don’t come under normal treatment guidance.
“Traditionally, people had said sort of small babies didn’t get malaria because they were protected by maternal immunity, but I think we’re increasingly recognizing that burden in very small children is not insubstantial and they just present in very different ways. Even very low levels of parasites can give fairly significant severe malaria and death,” she told The Washington Post in a phone interview Tuesday.
Rao, who has also worked with Doctors Without Borders to help fight malaria in Africa, said families have had to grind up tablets, use syringes or have their child treated in a hospital, all of which can provide barriers to effective treatment.
“This is a drug that can be mixed with breast milk, which is brilliant and much easier to deliver,” she said.
Malaria vaccines can be given to children from around 5 months of age, delivered in four doses, according to the WHO. By April, vaccines were being rolled out across 19 nations to “unprecedented” demand, the WHO said.
Novartis CEO Vas Narasimhan said the company has worked to fight malaria for three decades and is “proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”
Novartis plans to introduce the treatment on a largely nonprofit basis in areas where malaria is endemic, it said.
About 95 percent of malaria deaths and cases take place in the WHO’s Africa region, and insufficient funding means that many lifesaving tools, such as insecticide-treated nets and medicines, do not reach the most vulnerable, the WHO says.
Climate change is also affecting transmission of the disease. By 2040, the combined effects of longer seasons for mosquitos to spread the disease and demographic growth could put more than 5 billion people at risk of contracting malaria worldwide, including a billion on the continent of Africa alone, The Washington Post has previously reported.
In recent years, some doctors and scientists have argued for using gene editing to suppress mosquitoes or eliminate them altogether – even as others have warned that this raises serious ethical questions.
