2014年10月3日讯 /生物谷BIOON/ --早在2009年，FDA首次表达了对服用哮喘药物索雷尔（Xolair，通用名：omalizumab,奥马珠单抗）患者中发生的心脏发作和中风报道表达了关注，该药由罗氏（Roche）和诺华（Novartis）联合销售。近日，FDA将采取行动，在Xolair标签上添加新的警告信息，确认该药与心血管疾病风险相关。
根据FDA公告，该警告信息不会以“黑框警告”纳入Xolair标签，而是纳入产品标签的“不良反应”部分。这对罗氏和诺华来说，应该是算个好消息。
而坏消息是，这些警告信息多少有点吓人。FDA审查了一项5年研究及25项比较Xolair和安慰剂的临床试验数据，确定Xolair提高了心血管疾病风险，包括血栓、心脏发作、中风、肺动脉高压等。不过，在公告中FDA称，鉴于该项5年研究的设计问题，无法确定Xolair升高的风险究竟有多大。
罗氏和诺华表示，已就Xolair标签更新与FDA进行了密切合作。根据路透社获得的一份声明，罗氏和诺华表示，患者的安全始终是第一位的，公司相信Xolair的标签更新，将为医疗专业人士和患者提供最新的信息，以便做出明智的医疗决定。
Xolair于2003年获FDA批准用于常规类固醇吸入剂控制不佳的哮喘患者。该药在2013年的全球销售额达到了15亿美元。
今年，FDA和欧盟均批准Xolair治疗慢性特发性荨麻疹，Xolair的销售有望显著增长。诺华预测，其皮肤科药物在2014年的销售额将达到20亿美元，这不仅来源于Xolair，还来源于银屑病药物secukinumab，该药目前正在等待FDA的批准。FDA已安排一个专家委员会，将在10月20日讨论是否批准该药。
另一方面，罗氏正在开发新一代哮喘药物，来巩固Xolair的地位。今年3月，罗氏公布了单抗药物lebrikizumab的IIb期喜人数据，该药是一种抗IL-13单克隆抗体，靶向据认为可触发严重哮喘的细胞因子IL-13。该药被认为是罗氏管线中最看好的3个重磅药物之一，预计于2016年向欧美提交上市申请。
关于索雷尔（Xolair）：
Xolair（omalizumab）是一种实验性单克隆抗体，靶向结合免疫球蛋白E（IgE），该药可能通过减少IgE和细胞激活机制的下游效应，来抑制组胺诱导的皮肤反应。
目前，Xolair已获全球90多个国家批准，以品牌名索雷尔（Xolair）上市，用于治疗中度至重度持续性过敏性哮喘，该药由诺华和罗氏旗下基因泰克（Genentech）合作开发。（生物谷Bioon.com）
英文原文：FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair
It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis ($NVS) and Roche ($RHHBY). Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.
The warnings will not be contained in a prominent "black box" on Xolair's packaging but rather in the "Adverse Reactions" section of its label, according to an announcement from the FDA. That's the good news.
The bad news is that the warnings are somewhat scary. The FDA reviewed data from a 5-year study, along with 25 trials comparing Xolair to placebo, and determined that the drug raises the risk of problems occurring in the blood vessels of the heart and brain, including clots, heart attacks, mini-strokes, chest pain and pulmonary hypertension--high blood pressure in the lungs' arteries that can be life-threatening. Due to weaknesses in how the 5-year study was designed, however, the FDA is unable to determine exactly how big the risks are, the FDA says.
Roche and Novartis say they worked closely with the FDA on the updates. In a statement acquired by Reuters, the companies added that they were committed to patient safety and they believe "the revisions will provide healthcare professionals and their patients with the most up-to-date information to make informed healthcare decisions."
The FDA approved Xolair in 2003 to be used in patients whose asthma was not well controlled by commonly used steroid inhalers. But the drug has been a major success nonetheless, generating total sales of $1.5 billion for Roche and Novartis last year.
Xolair is poised for even more growth, thanks to European and U.S. approvals this year for the treatment of chronic idiopathic urticaria, a skin condition marked by chronic hives. The approvals prompted Novartis to predict its dermatology division would eventually be hauling in $2 billion in annual sales, not just from Xolair, but also from the company's psoriasis treatment secukinumab, which is currently awaiting FDA approval. The agency has scheduled an advisory committee meeting to discuss the psoriasis drug on October 20.
As for Roche, it's looking to bolster Xolair with the next generation of asthma fighters. In March, the company trumpeted positive Phase IIb data for lebrikizumab, an IL-13 antibody that targets a cytokine believed to trigger severe asthma. CEO Severin Schwan has pegged the drug as one of three big blockbusters in Roche's pipeline and expects it to start making its way to regulators in 2016.
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