The Swiss Agency for Therapeutic Products (Swissmedic) has approved Novartis’ Coartem (artemether-lumefantrine) Baby, described as the first malaria medicine for newborns and young infants.
Known as Riamet Baby in some regions, the new treatment is set to address a critical gap in malaria care for this vulnerable age group.
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The approval opens the door for eight African countries to expedite their approval processes, leveraging the Marketing Authorization for Global Health Products procedure.
Novartis is preparing to introduce the treatment, primarily on a not-for-profit basis, to improve access in malaria-endemic regions.
Novartis CEO Vas Narasimhan stated: “For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most.
“Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”
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By GlobalDataDeveloped in partnership with Medicines for Malaria Venture (MMV) and as part of the PAMAfrica consortium, the medicine has been designed to be dissolvable, even in breast milk, and has a sweet cherry flavour.
This innovation simplifies administration for the youngest patients.
Infants weighing under 4.5kg previously had no approved malaria treatment and were at risk of overdose and toxicity due to the use of older children’s formulations.
The Swissmedic approval is based on results from the Phase II/III CALINA study, which explored a new ratio and dose of Coartem to suit the metabolic needs of babies weighing below 5kg.
The treatment is now indicated for infants and neonates between 2kg and less than 5kg, targeting acute, uncomplicated infections caused by Plasmodium falciparum or mixed infections that include P. falciparum.
Novartis recently completed its acquisition of US-based biopharmaceutical company Regulus Therapeutics for $1.7bn, strengthening its renal disease portfolio.
