The new medicine, developed in partnership with Medicines for Malaria Venture, addresses a significant issue in treating malaria in infants.
Novartis announced that Swissmedic has granted approval for Coartem Baby (artemether-lumefantrine), marking it as the first malaria treatment designed specifically for newborns and young infants.
Created in partnership with Medicines for Malaria Venture (MMV), this new medication fills a significant void in the treatment of malaria for infants weighing under 4.5kg.The evaluation of Coartem Baby involved eight African nations, which are anticipated to provide swift approvals in accordance with Swissmedic’s Marketing Authorisation for Global Health Products procedure.
Novartis intends to launch a treatment suitable for infants primarily on a not-for-profit basis to improve accessibility in regions where malaria is endemic.
Novartis CEO Vas Narasimhan stated: “For over thirty years, we have remained committed to combating malaria, tirelessly striving to provide scientific advancements where they are most needed.
“Alongside our partners, we take pride in having developed the first clinically validated malaria treatment for newborns and young infants, ensuring that even the smallest and most vulnerable individuals can finally receive the care they rightfully deserve.”
Previously, there was no sanctioned malaria treatment for infants weighing less than 4.5kg, necessitating the use of formulations designed for older children, which carried risks of overdose and toxicity.Moreover, malaria vaccines have not been authorized for the youngest infants, further underscoring the necessity for this treatment.
A survey conducted across West Africa indicates that malaria infection rates range from 3.4% to 18.4% in infants under six months of age.
However, information regarding malaria in young infants is scarce due to their exclusion from clinical trials involving antimalarial medications.
The new dosage strength for young infants was developed by Novartis with assistance from MMV and the PAMAfrica consortium.
The treatment is designed to be dissolvable, even in breast milk, and features a sweet cherry flavor to ease administration.
MMV CEO Martin Fitchet remarked: “Malaria is one of the deadliest diseases globally, especially among children. However, with adequate resources and attention, it can be eradicated.
