Amarin's Vascepa will face FDA panel for CV risk reduction label


2019-08-13 12:07:34 FiercePharma


Everything has gone according to plan for Amarin’s fish-oil pill Vascepa, with scripts booming and a fast-track review underway for a label update. Only one thing could put a damper on the drug’s rosy outlook: the FDA taking a closer look at its cardiovascular benefits. And that's exactly what it plans to do.  The FDA will hold an advisory committee meeting Nov. 14 to review Amarin’s application to include a reduced risk of cardiovascular events in patients with abnormally high triglyceride levels on Vascepa’s label. The label decision was initially set for Sept. 28, but Amarin now says it could be delayed until late December. In a release, Amarin said the committee would likely target the results of Vascepa’s Reduce-It outcomes trial, which showed a 26% risk reduction for cardiovascular events over placebo. Those trial results, unveiled in October, were touted as a “landmark” achievement for Vascepa and a potential sign of a blockbuster drug in the making. RELATED: Amarin CEO: When it comes to Vascepa expansion, 'we can do this on our own' On the heels of those promising results, sales of the drug rocketed to $100.4 million in the second quarter—a 91% increase over the same period in the previous year. Amarin was so confident in those sales that it made the surprising decision in July to raise $400 million in cash to fund a massive commercial expansion on Vascepa’s expected label update, including doubling its sales force and fleshing out of its inventory to meet increased demand. In response to the FDA notice, Amarin said it would continue its sales hiring plan despite the delay to “better prepare” for the expected expanded launch. RELATED: Amarin's $400M-plus offering put investors on edge. Is a buyout off the table? While the FDA’s decision to take a second look at Vascepa’s results does mean a temporary setback in Amarin’s plans, that may not be a bad thing for the drug’s future, Jefferies analyst Michael Yee said. While an advisory committee meeting was unexpected, Yee said, it’s not unusual given the gravity of Vascepa’s results and what they could mean for the future of the drug and the cardiovascular field on the whole. “While some investors might be a bit upset/frustrated since they just raised money, we think this is a buying opportunity because it's not shocking to have a panel and this should get approved and go right back up,” Yee wrote in a note to investors. “Overall, we predict the FDA will approve the drug given clearly significant (and transformative) evidence of benefit for an unmet need.” RELATED: Amarin’s Vascepa cuts heart risks in key trial, but placebo noise fuels controversy One possible sticking point in the drug’s review is concern that issues with Reduce-It’s placebo arm skewed Vascepa’s trial results. Critics of the study said the placebo pill may have increased negative CV biomarkers, including bad cholesterol levels, but Yee noted that Amarin launched a post hoc review that found little connection between the placebo results and Vascepa’s benefits. If the FDA approves Vascepa’s label expansion, the drug could reach peak sales of between $2 billion and $3 billion, Yee said.
所有的事情都按照阿玛林的鱼油药片 Vacepa 的计划进行了,脚本蓬勃发展,并且正在进行标签更新的快速回顾。只有一件事能抑制药物的乐观前景: FDA 更仔细地审视其心血管的益处。 这正是它计划做的。 FDA 将于11月14日召开咨询委员会会议,审查 Amarin 的申请,包括降低 Vasicpa 标签上甘油三酯含量异常高的患者发生心血管事件的风险。 标签决定最初定于9月28日,但 Amarin 现在表示,可能会推迟到12月底。 在一份新闻稿中, Amarin 说,该委员会可能会将 Vacepa 的“减少排放”结果试验的结果作为目标,该试验显示,与安慰剂相比,心血管事件的风险降低了26%。去年10月公布的这些试验结果被认为是 Vacepa 取得的“里程碑”成就,也是该公司生产一种重磅炸弹药物的潜在标志。 相关: Amarin 首席执行官:谈到 Vasicpa 的扩张,我们可以自己做。 继这些有希望的结果之后,该药物的销售额在第二季度飙升至1.004亿美元,比上年同期增长91%。Amarin 对这些销售非常有信心,因此它在7月份出人意料地决定筹集4亿美元现金,为 Vasicpa 预期的标签更新项目进行大规模商业扩张提供资金,包括将销售队伍扩大一倍,并充实库存以满足不断增长的需求。 作为对 FDA 通知的回应, Amarin 表示将继续其销售招聘计划,尽管推迟“更好地准备”预期的扩大发布。 相关: Amarin 的4亿美元以上的发行使投资者处于有利地位。是不是被买断了? 杰富瑞( Jefferies )分析师迈克尔•耶伊( Michael Yee )表示,尽管 FDA 决定对 Vacepa 的业绩进行第二次评估,但这意味着 Amarin 的计划将暂时受挫,这对该药物的未来可能不是件坏事。 Yee 说,虽然咨询委员会的一次会议出人意料,但考虑到 Vacepa 研究结果的严重性以及它们对药物和心血管领域未来的意义,这并不罕见。 Yee 在给投资者的一份报告中写道:“尽管一些投资者可能会感到有些不安/沮丧,因为他们刚刚筹集到资金,但我们认为这是一个购买机会,因为设立一个专门小组并不令人震惊,这应该得到批准并重新开始。”“总体而言,我们预计 FDA 将批准这一药物,因为有明显的重大(且具有变革性)证据表明,该药物有利于未满足的需求。” 相关:阿马林的 Vasicpa 在关键试验中降低了心脏风险,但安慰剂噪音引发了争议 在该药物的研究中,一个可能的症结是担心服用安慰剂的人会扭曲 Vacepa 的试验结果。 该研究的批评者说,安慰剂可能增加了负性心血管生物标志物,包括坏胆固醇水平,但 Yee 指出, Amarin 启动了一项事后审查,发现安慰剂结果与 Vasicpa 的益处没有什么联系。 Yee 说,如果 FDA 批准 Vacepa 的标签扩展,该药物的最高销售额可能在20亿到30亿美元之间。