FDA panel backs Novartis malaria drug

Novartis has won the unanimous support of an FDA expert committee on the efficacy of its malaria drug Coartem, with only one holdout on the safety vote. Novartis has asked for the agency's approval to use Coartem--already in use in some 80 countries -- to treat malaria infections caused by the parasite P falciparam. While P falciparam affects some 200 million people worldwide, the parasite is linked to only about 1,500 infections per year in the U.S. Some of those cases are resistant to existing therapies.

Analysts note that Novartis' biggest reward for a formal approval of Coartem could come from a voucher program put in place last year to encourage the development of new therapies for tropical diseases. Novartis stands to win the right to use the voucher to gain a six-month review on a new drug of its choice, rather than the standard 10-month review, and that voucher could be sold for millions, according to the Guardian.  

- read the story [1]in the Wall Street Journal
- check out the report [2] from The Guardian

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Novartis' Coartem gets priority review status [4]