FDA Expected To Approve Novartis’ ACT Coartem for Malaria Treatment in U.S.
FDA is expected to approve Novartis' artemisinin-based combination therapy Coartem for treating malaria in the U.S., the New York Times reports. Coartem is a combination of the artemisinin derivative artemether and lumefantrine, a drug developed by Chinese scientists. Although lumefantrine does not kill parasites as quickly as artemether, it remains in the blood longer and thus helps prevent drug resistance. According to Novartis, FDA's deadline for a decision on the drug's approval was Dec. 26, 2008 (McNeil, New York Times, 12/23/08). An FDA advisory committee of independent experts in December 2008 unanimously said the drug was effective and voted 17-1 in favor of a question of the drug's safety (GlobalHealthReporting.org, 12/2/08). While Coartem is under review, Novartis is prohibited from any action that promotes sales of the drug to U.S. residents, the Times reports.FDA's approval of Coartem would make the drug available to U.S. residents planning to travel overseas and to the military. According to the Times, the U.S. reports about 1,500 malaria cases annually, primarily among travelers returning from tropical countries. Of those travelers, most are returning from visiting relatives, about 10% are tourists and about 2% are in the military. Although the drug is not intended to prevent malaria, travelers could carry Coartem with them and treat themselves if they begin to display malaria symptoms, Bradley Connor, founder of Travel Health Services, said. Alan Magill, physician and director of the experimental drugs division at Walter Reed Army Institute of Research, said registering Coartem also will benefit the military, which typically cannot prescribe drugs lacking FDA approval. Magill added that Coartem will not change how the military administers preventive malaria drugs but that it will give military doctors more flexibility in addressing the disease.
Since the introduction of Coartem in 2001, the drug has been approved in more than 80 countries, including 16 in Europe, the Times reports. Novartis currently sells Coartem to the World Health Organization and medical charities at production cost, or 80 cents per treatment course. According to Novartis, the company has sold almost 200 million treatments for use in Africa and has prevented 500,000 deaths from malaria. Although Novartis initially had little incentive to register Coartem in the U.S. because of a small market for the drug, the company received pressure to do so after the 2005 passage of the $1.2 billion President's Malaria Initiative. Magill predicted that Novartis will lose money on Coartem in the U.S. but added that the company had "its arm twisted by the government." Silvio Gabriel, Novartis' manager of malaria initiatives, added that Coartem is "basically for public relations." However, according to the Times, Novartis could benefit from an October law granting "priority review vouchers" to companies that register new drugs against tropical diseases such as malaria. According to FDA spokesperson Sandy Walsh, the voucher will allow the agency to review Novartis' next drug application in six months rather than in 10 to 12 months. Novartis also can sell the voucher, according to the Times. Gabriel called the voucher program a "gift from heaven" but added that Novartis might not qualify because it started the registration process in 2006, before the law creating vouchers went into effect (New York Times, 12/23/08). This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
