诺华（Novartis）3月31日宣布，基于令人信服的中期疗效数据并且已达到主要终点，数据监测委员会（DMC）一致建议提前终止心衰药物LCZ696的III期PARADIGM-HF研究。中期数据表明，与标准护理ACE抑制剂依那普利（enalapril）治疗组相比，LCZ696治疗组发生心脏衰竭住院的时间显著延迟。而此前的2项中期分析数据还表明，LCZ696具有可接受的安全性。
PARADIGM-HF是一项随机、双盲III期预后研究，在8436例伴有低射血分数的心脏衰竭患者中开展，评价了LCZ696相对于依那普利（enalapril，一种广泛使用的ACE抑制剂）的疗效和安全性。主要终点是首次出现心血管死亡或心脏衰竭住院的时间，该项研究也被设计成能够检测到心血管死亡的显著差异。该研究起始于2009年12月，是迄今为止在心脏衰竭群体中开展的最大临床试验。
PARADIGM-HF研究的结果将提交至未来的医疗会议。同时，诺华将启动与全球监管当局讨论该药的监管申请。
LCZ696是一种每日2次的口服药物，是由代文（Diovan，通用名：valsartan，缬沙坦）和另一类名为脑啡肽酶抑制剂的药物的复发药物，开发用于心脏衰竭的治疗。该药是一种首创新药，以多种方式作用于心脏的神经内分泌系统，阻断施加有害影响的受体，同时促进保护性机制。作为一种ARNI（血管紧张素受体脑啡肽酶抑制剂），LCZ696被认为能够减少正在衰竭的心脏的压力，同时能够促进心脏肌肉的能力。
LCZ696是诺华开发用于心脏衰竭的第2种药物，另一种药物RLX030（serelaxin）开发用于急性心脏衰竭的治疗。诺华是心血管药物领域的主要参与者，该公司正期望这2种心衰药物能够重振雄风，因为其最畅销高血压药物代文（Diovan）正面临仿制药竞争。
业内指出，LCZ696可能代表着诺华在心血管领域的又一个重磅药物，该药在近期内尚未有竞争对手。花旗银行分析师Andrew Baum预计，LCZ696的年销售峰值将达到50亿美元，有望成为近10年中获批用于慢性心力衰竭的首个新药。
LCZ696的利好消息与Serelaxin最近遭受的挫折形成了鲜明对比。上周，FDA顾问委员会建议不批准Serelaxin用于急性心力衰竭的治疗，理由是该药改善症状的证据不足，这与欧洲监管机构同样建议不批准Serelaxin的建议形成了呼应。
ZURICH (Reuters) - Novartis has ended a late-stage clinical trial of a chronic heart failure drug early, following strong interim results, giving the Swiss drugmaker a boost after recent setbacks to another heart failure medicine.
The Basel-based firm said on Monday an independent committee had unanimously recommended it close its PARADIGM-HF study ahead of time after results showed patients receiving its LCZ696 drug lived longer without being hospitalized for heart failure than those who were given enalapril, the standard care.
The Swiss drugmaker, long a major player in cardiovascular medicine, is looking to LCZ696 as one of two new treatments for heart failure that could revive its fortunes as top-selling blood pressure pill Diovan faces generic competition.
Novartis said it would present the full data at an upcoming conference and seek approval for the drug from global regulators.
"If full results are robust, LCZ696 could represent another blockbuster drug in the category of cardiovascular medicine that the company knows well," Bernstein analyst Tim Anderson said, adding he was aware of no near-term competitors for the drug.
Citi analyst Andrew Baum said the drug could have the potential to achieve peak annual sales of more than $5 billion and could become the first new medicine to be approved for chronic heart failure in over a decade.
At 0840 GMT, shares in Novartis were up 1.9 percent at 74.35 Swiss francs, outperforming a 0.5 percent firmer European healthcare sector index.
The positive news for LCZ696 contrasts with recent setbacks for Novartis' other acute heart failure drug, Serelaxin.
Last week, a panel of advisers to the U.S. Food and Drug Administration recommended Serelaxin not be approved because of insufficient evidence it improves symptoms, echoing a recommendation by European regulators which also ruled against the drug.
Heart failure is a condition where the heart struggles to pump blood around the body. Unlike a heart attack, in which a heart artery becomes blocked, it develops progressively.
More than 20 million people suffer from heart failure in Europe and the United States alone, Novartis said.
LCZ696, a twice a day pill, is a combination of Diovan, or valsartan, and another class of drug called a neprilysin inhibitor.
The study was eva1uating LCZ696 in patients with so-called reduced ejection fraction chronic heart failure.
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