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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
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“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
“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.
