FDA批准了第一個治療天花的藥物
FDA approves the first drug with an indication for treatment of smallpox
FDA批准了第一個含有治療天花適應症的藥物
時間 | July 13, 2018
來源 | FDA
編譯 | Vivian
The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.
美國食葯監局近日批准TPOXX（tecovirimat）上市，這是第一個含有治療天花適應症的藥物，雖然世界衛生組織於1980年宣布消滅了天花，這是一種具有感染性並且有時候是致命的傳染性疾病，但是已經長期存在的天花病毒可能會被用來當作生化武器。
「To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. Today』s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon,」 said FDA Commissioner Scott Gottlieb, M.D. "This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today』s action reflects the FDA』s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.」
「為了處理生物恐怖主義的風險，國會已採取步驟, 促使發展和批准反制措施, 以挫敗可能被用作生物武器的病原體。今天的批準是這些努力重要的里程碑，如果天花被用作生化武器，這一新的治療方法給予了我們一個額外選擇，」FDA局長Scott Gottlieb, M.D說，「這是第一個被授予物質威脅醫療對策優先審評券的產品。今天的行動反映了FDA的承諾，即確保美國為任何突發公共衛生事件做好準備，提供及時，安全和有效的醫療產品。」
Prior to its eradication in 1980, variola virus, the virus that causes smallpox, was mainly spread by direct contact between people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache and backache. A rash initially consisting of small, pink bumps progressed to pus-filled sores before finally crusting over and scarring. Complications of smallpox could include encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye) and blindness.
在1980年消除天花之前，引起天花的天花病毒主要依靠人與人之間直接接觸而蔓延，典型的癥狀開始於被感染後的10至14天之後，包括發熱、精疲力竭、頭疼和背疼，一種皮疹由最初小的粉紅色的腫塊發展為充滿膿的潰瘍，最後結痂並結疤，天花的併發症包括腦炎（大腦的炎症）、角膜潰瘍（在眼睛清澈前表面上的開放性的潰瘍）和失明。
TPOXX』s effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox, and was based on measuring survival at the end of the studies. More animals treated with TPOXX lived compared to the animals treated with placebo. TPOXX was approved under the FDA』s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
TPOXX治療天花的有效性是通過對感染了與天花病毒密切相關的病毒的動物的研究而確定的，並且基於研究結束時的生存狀況，與安慰劑組相比，接受TPOXX治療的動物存活率更高。TPOXX是根據FDA的動物規則批准的，該規則允許在不可行或不符合倫理的情況下，從足夠的、嚴格控制的動物研究中獲得的療效發現支持FDA的批准。
The safety of TPOXX was evaluated in 359 healthy human volunteers without a smallpox infection. The most frequently reported side effects were headache, nausea and abdominal pain.
TPOXX的安全性在359名沒有天花感染的健康志願者中進行了評估，最常見的副作用是頭痛、噁心和腹痛。
The FDA granted this application Fast Track and Priority Review designations. TPOXX also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases and a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.
FDA准予了這一申請的快速通道和優先審評，TPOXX還獲得了孤兒葯認定,這激勵了協助和鼓勵開發罕見病藥物。而且物質威脅醫療對策優先評審券是為某些旨在治療或預防特定化學，生物，放射和核威脅傷害的醫療產品提供額外獎勵
The FDA granted approval of TPOXX to SIGA Technologies Inc.
FDA批准了SIGA技術公司的TPOXX。
TPOXX was developed in conjunction with the U.S. Department of Health and Human Services』 Biomedical Advanced Research and Development Authority (BARDA).
TPOXX是與美國衛生部和人類服務部的生物醫學高級研究與發展管理局(BARDA)合作開發的。
FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation』s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA是美國衛生與公眾服務部的一個機構，通過確保人類和獸用藥，疫苗和其他人用生物製品以及醫療器械的安全性，有效性來保護公眾健康。該機構還負責美國食品供應、化妝品、膳食補充劑、電子輻射產品的安全以及監管煙草產品。
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