Novartis has been boosted by a recommendation from a US advisory panel that its malaria drug Coartem is safe and effective.

The US Food and Drug Administration's Anti-Infective Drugs Advisory Committee voted unanimously in favour of the efficacy of Coartem (artemether/lumefantrine), while the panel voted 17-1 on its safety.
The drug is already approved in 83 countries and Novartis supplies it provides to developing countries at cost.

However the Swiss firm is hoping to get regulatory approval for Coartem in the USA as a treatment for malaria infections caused by the parasite Plasmodium falciparum, the most dangerous form of the mosquito-borne disease. Malaria is not a major problem across the Atlantic, but about 1,500 cases are reported each year and Novartis noted that with increasing international travel, the numbers of patients returning to the USA from endemic countries is set to increase, particularly as increasing drug resistance” occurs with the most dangerous strain of the disease.

If the FDA grants full approval (its decision is due on December 26), Coartem could be worth around $500 million in US sales, analysts believe.