FDA grants priority review status to Novartis' ACT Coartem

Sep 16 2008

Swiss pharmaceutical company Novartis on Monday announced that FDA has granted priority review status for its malaria treatment Coartem, Dow Jones reports.

Coartem is a fixed-dose artemisinin-based combination therapy and has been found to be 96% effective in treating malaria, even in areas of multi-drug resistance. The drug, which is used widely in Africa, has been recommended by the World Health Organization and approved in 80 countries (Greil, Dow Jones, 9/15).

If FDA approves Coartem, the drug would be the first ACT approved for malaria treatment in the U.S. (Thomasson, Reuters, 9/15). Priority review, which FDA grants to drugs that address "urgent unmet health issues," reduces the review time for new drug applications from 10 months to six months (Dow Jones, 9/15).

Daniel Vasella, Novartis chair and CEO, said that he is "pleased that Coartem has been granted priority review by the FDA," adding that the company has supplied 195 million doses of Coartem, which has helped prevent nearly 500,000 malaria deaths. Tim Ziemer, coordinator of the President's Malaria Initiative, said that PMI was "pleased" to learn of Novartis' application, adding that Coartem "has already had an important impact in controlling malaria in Africa" (Novartis release, 9/15).