《专家建议FDA批准降低胆固醇新药》.doc

An?expert?group?recommended?on?Tuesday?that?the Food?and?Drug?Administration?approve?a?powerful new?drug?to?protect?against?heart?attacks.?If approved,?it?would?be?the?first?in?a?major?new?class of?medicines?in?a?generation?that?significantly?lower levels?of?cholesterol,?the?leading?cause?of?heart disease. 周二，一批专家建议美国食品与药品管理局（Food?andDrug?Administration，简称FDA）批准一种预防心肌梗死的强效新药。如果获得批准，该药物将成为一个新的重要药物类别中，最近二三十年获批的首例药物。此类药物能大幅降低胆固醇水平，而胆固醇是心脏病的主要诱因。 Dr.?Joshua?W.?Knowles,?a?Stanford?cardiologist,?called?the?medicines?“a?triumph?of?themodern?genetic?revolution.” 斯坦福大学(Stanford)的心脏病学专家约书亚·W·诺尔斯(Joshua?W.?Knowles)博士称，这些药物是“现代基因革命的一次胜利”。 The?idea?for?such?drugs?arose?from?genetic?studies?about?a?decade?ago?and?has?tantalized cardiologists?ever?since.?Early?results?of?clinical?trials?raised?hopes?that?the?therapies?would?be critical?new?additions?to?the?treatment?arsenal?for?those?at?risk?of?heart?disease,?the?biggest killer?of?Americans. 研制这类药物的想法来自于约10年前的基因研究成果，此后一直令心脏病学专家可望而不可即。初步的临床试验结果带来了希望，这些疗法可能为心脏病高危人群的治疗方法提供新的重要补充。心脏病是美国人的头号杀手。 People?who?have?taken?them?have?seen?their?LDL?cholesterol,?the?so-called?bad?cholesterol,plunge?to?remarkably?low?levels.?But?definitive?evidence?of?the?drugs’?effectiveness?in reducing?heart?attacks?and?deaths?will?only?come?after?large?clinical?trials?are?completed?in 2017. 服用这些药物的人已经发现体内的低密度脂蛋白(LDL)胆固醇显著下降，LDL胆固醇也就是所谓的“坏胆固醇”。不过，这种药物降低心梗和死亡风险的确凿证据，要到2017年大规模临床试验完成后才可能出现。 The?panel,?in?a?13?to?3?vote,?recommended?the?approval?of?Sanofi?and?Regeneron Pharmaceuticals’?drug,?alirocumab.?On?Wednesday,?the?committee?will?turn?to?Amgen’s?drug,evolocumab.?The?F.D.A.?usually?follows?the?recommendations?of?its?advisory?panels,?but?not always.?The?agency?says?that?if?it?approves?the?drugs?based?on?their?effects?on?cholesterol,?the approval?will?not?be?rescinded?even?if?trials?now?underway?fail?to?show?the?drugs?reduce?the risk?of?heart?attacks?and?deaths. 这个专家委员会以13比3的投票结果，建议批准赛诺菲(Sanofi)和瑞泽恩制药公司(RegeneronPharmaceuticals)的药物alirocumab。周三，这个委员会将开始评估美国安进