Novartis granted priority review for malaria drug

Coartem, a fixed-dose combination of two antimalarials, is said to be a highly effective three-day malaria treatment that according to studies achieves cure rates of over 96% even in areas of multi-drug resistance.

Recommended by the World Health Organization and widely used in Africa, Coartem could become the first artemisinin-based combination treatment (ACT) approved for use by the FDA.

Currently approved in more than 80 countries, including 16 European nations, Coartem is said to be the only fixed-dose ACT that has been approved by internationally recognized stringent health authorities. In these countries, it is indicated for the treatment of acute uncomplicated infections due to plasmodium falciparum, the most dangerous form of malaria.

Daniel Vasella, chairman and CEO of Novartis, said: “I am pleased that Coartem has been granted priority review by the FDA. In the fight against malaria, we have supplied 195 million treatments of Coartem without profit, helping to save the lives of close to 500,000 people suffering from malaria. Now Coartem has the potential to be the first ACT approved in the US.”