Novartis’ malaria drug for newborns cleared by WHO

The WHO has given a seal of approval to the world’s first malaria drug aimed at the smallest patients, clearing the way for it to be included in national treatment programmes.

The drug, marketed as Coartem Baby, has a sweet cherry flavour and was developed for infants weighing between two and five kilograms.

It fills a treatment gap, as there was previously no malaria drug approved for children under 4.5 kilograms, meaning that smaller babies were treated with drugs designed for older kids, increasing the risk of toxicity.

“As doctors we’ve tended to look for malaria in older children, but when newborn babies got sick nobody seemed to know what to do,” said Dr Emmanuel Aidoo, a paediatrician at Methodist Hospital in Ankaase, Ghana.

“Having a new treatment tailor-made for infants that is well tolerated gives us confidence.”

Coartem Baby was developed by Novartis with scientific and financial support from the Medicines for Malaria Venture, and with funding from the European and Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.

In deciding to give the drug prequalification, the WHO is confirming that it meets international standards of quality, safety and efficacy, enabling global health organisations to include the treatment in their programmes.

“This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them,” said Lutz Hegemann, president of global health at Novartis. “We have already introduced the treatment in Ghana and are pleased to now be going further together with our partners to reach even more of the smallest malaria patients.”