ST LOUIS (MD Consult) - On July 16, 2009, the US Food and Drug Administration (FDA) announced that it is evaluating interim safety findings from an ongoing study of Xolair (omalizumab), a drug indicated for the treatment of asthma associated with allergies.

The findings under FDA examination are from the study titled, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). EXCELS is an observational study of approximately 5000 Xolair-treated patients and a control group of approximately 2500 non-Xolair–treated patients. The primary objective of the study is to assess the long-term safety profile of Xolair over a 5-year period. Patients in the study are aged 12 years and older, experience moderate to severe persistent asthma, and have tested positive for an aeroallergen.

The interim data, submitted by the manufacturer of Xolair (Genentech), suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with Xolair compared with the number of such events in the control group.

The FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, health care providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

The FDA is working with Genentech to obtain further information and plans to continue to review the strengths and limitations of these interim results. For example, because EXCELS is an observational study, differences in underlying risk factors for cardiovascular and cerebrovascular events could exist between the 2 study groups. The FDA plans to communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.

The FDA is urging both health care professionals and patients to report adverse effects from the use of omalizumab to its MedWatch Adverse Event Reporting program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or by fax to 1-800-FDA-0178.

 

圣路易斯(MD Consult)——2009年7月16日，美国食品药品管理局(FDA)宣布，当局正对一项进行中的有关Xolair(奥马佐单抗，一种过敏性哮喘的治疗药)研究的中期安全性结果进行评价。

 

FDA所检测的结果来自标题为“中重度哮喘患者的临床疗效和长期安全性评价”(EXCELS)这项研究。EXCELS是对将近5,000例接受Xolair治疗的患者进行的一项观察性研究，对照组为大约2,500例未接受Xolair治疗的患者，其主要研究目的为评估5年中Xolair治疗的长期安全性。其受试者为年龄在12岁或12岁以上、有中重度持续性哮喘发作史且气源性致敏原检测阳性的患者。

Xolair生产厂家基因泰克提交的中期数据显示，与对照组相比，Xolair治疗组患者缺血性心脏病、心律失常、心肌病和心力衰竭、肺动脉高压、脑血管疾病、以及栓塞性、血栓形成性和血栓性静脉炎事件均有不同比例的增加。

FDA不建议对Xolair的处方资料做任何改动，亦不建议患者当下停用此药。在EXCELS研究评估完成之前，医护人员和患者应了解处方资料中描述的风险与获益，并及时从正在进行中的EXCELS研究获知提示心脑血管不良事件风险的最新信息。

FDA将与基因泰克公司合作以获得更多的资料，并计划继续审查这些中期结果的有效性和局限性。例如，鉴于EXCELS是一项观察性研究，故2个研究组之间在心血管和脑血管事件潜在危险因素方面可能存在差异。FDA拟于中期安全性数据分析完成时公布所有新结果。目前EXCELS研究正在进行之中，预计将于2012年获得最终研究结果。

FDA鼓励医护人员和患者将应用奥马佐单抗的不良反应报告至其MedWatch 不良事件报告系统，具体方法包括：上网在线报告，或致电(1-800-FDA-1088)，或者将邮资已付的FDA 3500表邮寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787，或发传真至1-800-FDA-0178。