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Novartis's antimalarial Coartem gets US panel scrutiny

This article was originally published in Scrip

Executive Summary

Novartis's NDA for the combination antimalarial, Coartem (artemether plus lumefantrine) will be reviewed by the US FDA's anti-infective drugs advisory panel on December 3rd. The proposed indication is treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or mixed infections including P falciparum. The NDA is undergoing a priority review; it was submitted in June and a decision is expected by year-end. Coartem is approved in more than 80 countries and widely used in Africa, where Novartis said it has provided more than 195 million treatments without profit. If approved it would be the first artemisinin-based combination treatment licensed by the FDA. It also could become the first medicine approved under the new priority review voucher programme for tropical disease treatments that was established by the FDA Amendments Act.

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