Swissmedic has approved Novartis’ Coartem Baby as the first malaria medicine for newborns and young infants, the company announced on Tuesday. The treatment was developed in collaboration with the Medicines for Malaria Venture (MMV).
Coartem, a treatment for malaria. Credit: Palb Pharmaceuticals
Novartis plans to distribute the treatment on a not-for-profit basis to areas where malaria is endemic. This includes the eight African countries participating in Swissmedic’s Market Authorization for Global Health Products (MAGHP) procedure: Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda. The procedure aims to accelerate access to interventions and therapeutic products in low and middle-income countries.
It is estimated that 30 million babies are born in areas of malaria risk in Africa annually. One survey by the CDC reported infections ranging between 3.4% and 18.4% in infants younger than six months in West Africa.
The new dose strength of Coartem (artemether/lumefantrine) designed for infants was developed as part of the PAMAfrica consortium, which is funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The treatment is dissolvable in breast milk and has a cherry flavor.
Filling a gap in treatment
This is the first malaria treatment approved for infants who weigh less than 4.5 kilograms (9.9 pounds). According to the WHO, the average birth weight of a full-term male baby is 3.3 kg (7 lb 6 oz) and the average birth weight of a full-term female baby is 3.2 kg (7 lb 2 oz), leaving many infants ineligible for the treatment.
According to the World Population Review, Burkina Faso, one of the African countries expected to approve Coartem Baby, has an estimated low birth weight rate of 18.5%. Low birthweight is defined as less than 2.5 kg (5.51 lb). The other countries in the program also have heightened low birth weight rate estimates: Kenya 10%, Malawi 15.6%, Mozambique 17.8%, Tanzania 9.7%. In comparison, the estimated low birth weight rate in the U.S. is 8.3%. Infants in these countries not only have a higher risk of contracting malaria, but are also ineligible for treatment for a longer period due to the prevalence of low birth weight.
Infants under the 4.5 kg weight threshold have been treated with formulations intended for older children, increasing the risk of overdose and toxicity. Additionally, malaria vaccines are not approved for babies under 5 months old. Coartem Baby fills a gap in malaria treatment for a particularly vulnerable population.
A novel clinical trial
The approval is based on results from the phase 2/3 CALINA study. The study demonstrated that the formulation of Coartem for babies weighing less than 5 kg with malaria has the required pharmacokinetic profile as well as efficacy and safety. This was the first evidence-based trial to evaluate a new dose and regimen for a malaria treatment for all infants weighing under 5 kg with acute uncomplicated malaria.
“Infants below 5 kg make up a critical neglected group, and developing antimalarials specifically suited to their needs is essential to malaria control efforts,” said Wiweka Kaszubska, Executive Vice President, Head of Product Development, MMV. “The success of the CALINA trial brings us one step closer to ensuring that all patients have access to appropriate and effective treatments.”
Coartem and Novartis: a market overview
The Coartem market size was estimated at $1.2 billion in 2024 by Verified Market Reports. Analysts expect the market for Coartem to grow by 9.1% from 2026 to 2033, reaching $2.5 billion by 2033. Many countries use Coartem as the first-line treatment for uncomplicated malaria. However, Novartis also distributes Coartem as a mostly not-for-profit endeavor to advance access to malaria treatment in low-income countries.
Novartis is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland. According to Forbes, the company made $48.7 billion in revenue in 2024. Novartis reported $50 million in net sales in 2024.
About malaria
Malaria is a life-threatening parasitic disease spread to humans through mosquito bites. According to the WHO, there were 263 million cases of malaria and 597 deaths in 2023. The WHO Africa region accounted for 94% of these malaria cases and 95% of deaths. Children under 5 accounted for 76% of all malaria deaths in the region. Symptoms include fever, chills, headache, fatigue, confusion, seizures and difficulty breathing.
Filed Under: clinical trials
