Novartis has received approval in Switzerland for Coartem Baby, the first drug to treat malaria in babies and very young children, with eight African countries which participated in the assessment now expected to issue quick approvals for the treatment, reports Reuters.
The treatment, also known as Riamet Baby in some countries, was developed with scientific and financial support from Medicines for Malaria Venture (MMV), a Swiss non-profit group working to deliver medicines to treat, prevent and eliminate the disease.
The new infant version of the drug is dissolvable, including in breast milk, and has a sweet cherry flavour to make it easier to administer. It will be delivered largely on a not-for-profit basis, said Novartis.
Until now, there has been no approved malaria treatment for infants weighing less than 4.5kg, leaving a treatment gap.
Currently available malaria treatments have only been tested in children at least six-months-old, because the very young are usually excluded from treatment trials.
Previously, infants have used formulations meant for older children, increasing the risk of overdose. Malaria vaccines are also not approved for the youngest babies.
The eight countries that took part in the assessment were Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda.
Around 30m babies are born in areas of malaria risk in Africa every year, with one survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants under six-months-old.
See more from MedicalBrief archives:
Africa’s challenge with malaria eradication
Novartis testing new anti-malaria pill in Africa
First malaria vaccination for children launched in Malawi
GSK’s novel malaria treatment for children receives first approval