Positive Data of Coartem for Malaria in Infants Weighing Less Than 5 kg

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The data were previously presented at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference and have been submitted for regulatory review.

Artemether-lumefantrine (Coartem; Novartis) has demonstrated the required pharmacokinetic profile with good efficacy and safety for infants weighing less than 5 kg with malaria, according to a press release from the company. The data were previously presented at the Multilateral Initiative on Malaria 8th Pan-African Malaria Conference and have been submitted for regulatory review.1

Malaria parasite Plasmodium falciparum in schizont stage inside red blood cells | Image Credit: Dr_Microbe - stock.adobe.com

Image Credit: Dr_Microbe - stock.adobe.com

“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," Shreeram Aradhye, president of development and chief medical officer at Novartis, said in the 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.”1

Treatment options for this patient population in the acute phase are the same as the adults, except the drug dose is adjusted for weight of the patient, and the dose should never exceed the recommended adult dose, according to the CDC. The treatment options include artemether-lumefantrine and atovaquone-proguanil (Malarone; GSK).2

The CALINA trial (NCT04300309) was designed to evaluate the pharmacokinetics, safety, tolerability, effectiveness, for the new formulation of the tablets in neonates and infants weighing less than 5 kg who have acute uncomplicated Plasmodium falciparum malaria, according to the clinical trial information. Infants were included if they had a body weight of 2 kg to less than 5 kg and a confirmed diagnosis of malaria. They were separate into 2 cohorts: one included aged over 28 days and the other aged 1 to 28 days. Cohort 2 was split into 3 subgroups including aged 1 to 7 days, 8 to 14 days, 15 to 28 days.3

This study is the first evidence-based trial for a new antimalarial dose and regimen for all infants weighing under 5 kg with acute uncomplicated malaria. There are no current antimalarials that have been developed specifically for this patient population.1

Key Takeaways

  1. Novartis' new formulation of artemether-lumefantrine shows promise for treating malaria in infants under 5 kg.
  2. This is the first-ever evidence-based trial for a new malaria treatment specifically designed for these infants.pen_spark
  3. The CALINA trial demonstrated good efficacy and safety of the new formulation.

“Infants below 5 kg make up a critical neglected group, and developing antimalarials specifically suited to their needs is essential to malaria control efforts,” Wiweka Kaszubska, executive vice president and head of product development at Medicines for Malaria Venture. “The success of the CALINA trial brings us one step closer to ensuring that all patients have access to appropriate and effective treatments.”1

Recently in March 2024, the FDA approved cobas Malaria (Roche) for use on the cobas 6800/8800 systems to reduce the potential risks of patient infection from transfused blood products. Malaria is a serious infection transferred by mosquitoes, but can also be transmitted through blood transfusion, organ transplant, or shared needles or syringes.4 Research is still being done in this area.

References
  1. Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria. News release. Novartis. April 24, 2024. Accessed May 9, 2024. https://www.novartis.com/news/media-releases/novartis-and-medicines-malaria-venture-announce-positive-efficacy-and-safety-data-novel-treatment-babies
  2. Centers for Disease Control and Prevention. Treatment of Malaria: Guidelines for Clinicians (United States). June 28, 2023. Accessed May 9, 2024. https://www.cdc.gov/malaria/diagnosis_treatment/clinicians1.html
  3. Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (CALINA). ClinicalTrials.gov identifier: NCT04300309. Updated February 9, 2024. Accessed May 9, 2024. https://clinicaltrials.gov/study/NCT04300309?term=CALINA&rank=1#publications
  4. McGovern G. FDA Approves Cobas Malaria to Help Reduce Risks Infections From Transfused Blood Products. Pharmacy Times. March 26, 2024. Accessed May 9, 2024. https://www.pharmacytimes.com/view/fda-approves-cobas-malaria-to-help-reduce-risks-infections-from-transfused-blood-products
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