ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Coartem tablets (artemether and lumefantrine) for treating acute, uncomplicated malaria infections in adults and children weighing at least 5 kilograms (approximately 11 pounds).

"Malaria is a global life-threatening disease," said Murray M. Lumpkin, MD, deputy commissioner for International and Special Programs, FDA. "It is encouraging to have new treatment available, particularly for children."

Coartem is not approved for treating severe malaria nor for preventing malaria. Severe malaria is different than acute, uncomplicated malaria in that patients with severe malaria have altered consciousness and other metabolic and end-organ complications. These patients are not candidates for oral drugs and should be given intravenous antimalarial therapy.

Malaria is a serious public health problem in many parts of the world. People from the United States who live in or travel to high-incidence areas are at risk of infection. Malaria is transmitted when a person is bitten by an infected mosquito. Coartem has been shown effective in geographic regions with reported resistance to chloroquine, a drug that prevents and treats malaria.

"Because of concerns about drug resistance with currently available drug therapy, it will benefit patients to have another treatment option for malaria available," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Symptoms of malaria include fever, chills, and flu-like illness. If untreated, the disease can cause severe complications, including death. About 90% of malaria deaths occur in Sub-Saharan Africa, but the disease is also prevalent in parts of Asia and Latin America. It is estimated that 350 to 500 million new cases develop worldwide annually, and 1 million patients, primarily young children, die of the disease.

Coartem should be taken with food, particularly food that contains fat, because this allows the body to absorb the drug well.

The most common adverse reactions to Coartem shown in clinical trials with adults are headache, anorexia, dizziness, physical weakness (asthenia), joint pain (arthralgia), and muscle pain (myalgia). The most common adverse reactions reported in children are fever (pyrexia), cough, vomiting, loss of appetite, and headache.

Artemether, one of the active ingredients in Coartem tablets, is the first artemesinin class drug approved in the United States. The artemesinins are derived from the leaves of the Artemisia annua plant used to treat malaria.

In compliance with a provision of the FDA Amendments Act of 2007, the FDA awarded Novartis a one-time priority review voucher to use toward a future new drug application. The provision, designed to encourage development of drugs to treat tropical diseases, authorizes granting such vouchers to sponsors of treatments for certain tropical diseases. The voucher may be transferred by the recipient to another manufacturer.

Coartem is made by Novartis Pharmaceuticals Corporation, Basel, Switzerland.
 

圣路易斯(MD Consult)——美国食品和药物管理局(FDA)已批准Coartem片(成分为蒿甲醚和苯芴醇)用于治疗急性无并发症疟疾感染的成年人和体重超过5公斤的儿童患者。

 

“疟疾是一个全球性、危及生命的疾病。” FDA国际和特别项目处副主任Murray M.Lumpkin博士说，“令人鼓舞的是有了新的治疗方法，尤其是对儿童有了有效治疗药物。”

 

但FDA没有批准Coartem片用于治疗重症疟疾，而且该药也不能用于预防目的。重症疟疾不同于急性、无并发症疟疾，重症疟疾的患者会出现意识混乱和其他代谢及终末器官的并发症。这些患者都没有高效的口服药物可以选择，只能给予静脉注射进行治疗。

 

疟疾已成为世界上许多地区一种严重的公共健康问题。居住在或旅行于这些高发病率地区的美国人面临感染疟疾的风险。受感染蚊子可通过叮咬在人群中传播疟疾。Coartem在对疟疾防治药物氯喹已产生耐药的地理区域已显示出其有效性。

“由于担忧对现有治疗药物产生耐药，此时选择其他的疟疾防治药物将有利于患者的治疗。” 美国FDA药物评价和研究中心抗菌药物办公室主任、公共卫生硕士和医学博士Edward Cox说。

 

疟疾的临床表现包括发烧、寒战和流感样症状。如果不加以治疗，该疾病可引起严重的并发症，包括死亡。约90%的疟疾死亡病例发生在撒哈拉以南非洲，但在亚洲部分地区和拉丁美洲也很普遍。据估计，每年在全世界范围内新发病例约3.5亿至5亿，有100万例死于该病，其中主要是儿童。

 

此药应与食物特别是含有脂肪的食品同时服用，以利于机体更好地吸收药物。

 

Coartem的临床试验中，成年人最常见的不良反应有头痛、食欲不振、头晕、身体虚弱、关节痛和肌肉疼痛。儿童最常见的不良反应有发烧、咳嗽、呕吐、食欲不振和头痛。

 

Coartem片活性成分之一的蒿甲醚是在美获批的首个青蒿素类药物。青蒿素可用于治疗疟疾，提取自植物黄花蒿的叶子。

 

根据FDA在2007年的修正法案的规定，将作为有未来应用前景的新药采取一次性优先审查证书授予诺华，这种方式也是为了鼓励治疗热带疾病药物的开发，该授权证书可由接受人转让给其他的制造商。

 

Coartem是由位于瑞士巴塞尔的诺华制药公司研制生产。