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Novartis, Medicines for Malaria Venture Release Positive Results from Phase II/III Trial of Coartem for Infants with Malaria


Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

Malaria positive. Image Credit: Adobe Stock Images/jarun011

Image Credit: Adobe Stock Images/jarun011

Novartis and Medicines for Malaria Venture (MMV) have announced promising results from the CALINA Phase II/III study evaluating a new formulation of Coartem as a treatment for infants under 11 lbs. with malaria. The study, conducted across Africa, found that the formulation showed promise when it came to safety and efficacy for this patient population. According to a joint press release, the CALINA study is the first evidence-based trial to evaluate a new antimalarial dose and regimen for all infants weighing under 11 lbs. with acute uncomplicated malaria.1

“We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment to all age groups, including vulnerable newborn babies," said Shreeram Aradhye, president, development, chief medical officer, Novartis, in a press release. “We have been committed to the fight against malaria for more than two decades, and this successful trial represents another milestone towards ensuring that all people have access to an appropriate antimalarial therapy.”

Coartem was first approved by the FDA in 2009 as an artemisinin-based combination treatment for malaria. The first formulation was a fixed-dose combination of two novel antimalarials, designated as a three-day malaria treatment with cure rates of over 96% at the time.2

"Around the world, Coartem has eliminated suffering for millions and saved lives for hundreds of thousands of malaria patients," said Daniel Vasella, MD, former chairman & CEO, Novartis, in a press release. "With a growing number of malaria cases in the US due to rising travel, it is important to make ACT treatment such as Coartem, the most effective therapy for malaria, available to American patients as well."

According to the World Health Organization (WHO), there were around 247 million cases of malaria globally. Additionally, 63,000 deaths from malaria between 2019 and 2021 were attributed to service disruptions as a result of the COVID-19 pandemic. Despite the disease being reported in 84 countries across five WHO regions, Europe has been malaria-free since 2015. In Africa, 78.9% of all deaths of children under 5 years of age were attributed to malaria. Further, it was attributed to 96% of all malaria deaths globally.3

“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, EVP, head of product development, MMV, in a press release. “The success of the CALINA trial brings us one step closer to ensuring that all patients have access to appropriate and effective treatments.”


1. Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria. Novartis. April 24, 2024. Accessed April 25, 2024. https://www.novartis.com/news/media-releases/novartis-and-medicines-malaria-venture-announce-positive-efficacy-and-safety-data-novel-treatment-babies

2. Coartem® receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US. GlobeNewswire. April 8, 2009. Accessed April 25, 2024. https://www.globenewswire.com/Tr/news-release/2009/04/08/1878556/0/en/Coartem-receives-FDA-approval-becoming-first-artemisinin-based-combination-treatment-ACT-for-malaria-in-the-US.html

3. Malaria. WHO. Accessed April 25, 2024. https://www.who.int/data/gho/data/themes/malaria

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