After Slow Start Entresto Is Poised For Takeoff

–Novartis sees open road to blockbuster status for heart failure drug After a slow start, the novel heart failure drug Entresto (valsartan/sacubitril) is now poised to become a blockbuster, if drugmaker Novartis’s projections are on target. The combination pill will record sales of about $500 million in 2017 and may eventually achieve $5 billion in…

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Novartis Withdraws Support For Controversial Entresto Contest

(Updated) Novartis will no longer sponsor a contest designed to support the publication of peer review articles about Entresto, the company’s important new heart failure drug. The contest is taking place on Cureus, an open access journal, publishing platform, and vehicle for industry-sponsored content. The contest offered $10,000 in rewards for articles supporting a recent…

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Novartis Contest Rewards Positive Peer Review Articles About Entresto

(See the bottom of the story for updates. Since the original publication of the story the cardiologists on the “peer review panel” have resigned and Novartis has withdrawn its support for the contest.) Despite the fact that it had one of the biggest clinical trial successes in recent years, the Novartis heart failure drug Entresto has…

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Debate: Switching From Standard HF Therapy To Entresto

–A debate at the HFSA in Orlando over whether all patients tolerating standard therapy should be switched to Entresto. Editor’s Note: Heart failure specialist Eiran Z. Gorodeski (Cleveland Clinic) wrote this account of an important debate on Monday at the Heart Failure Society of America meeting in Orlando. (This account has been updated by Gorodeski with…

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New Heart Failure Drug Struggles To Find Its Footing

–Experts offer insight about Entresto at the ESC. Despite its success in a large and widely praised clinical trial the novel heart failure drug Entresto (sacubitril/valsartan, Novartis) has been struggling to gain a substantial foothold in the marketplace. Now new papers and presentations and commentary from experts at the European Society of Cardiology meeting are…

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Entresto Gets Boost in Updated HF Guidelines

–Valsartan/sacubitril earns Class I recommendation Cardiology groups in the U.S. and Europe have updated their heart failure guidelines to include much-awaited recommendations for Entresto (the combination of valsartan and sacubitril manufactured by Novartis). The new guidelines offer broad support for the new drug. Since its approval last summer Entresto has struggled to gain a foothold…

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Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug

–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but slow starting heart failure drug Entresto (valsartan/sacubitril). The company said it would perform 40 clinical trials with the drug in the next five years. The Fortifying Heart Failure clinical evidence and…

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New Cardio Drugs Off To Very Slow Start

–Heart failure experts divided over how and when to use Entresto To many long-time observers, the approval last year of two new cholesterol drugs and a heart failure drug appeared to herald a rebirth of the cardiovascular marketplace after a long period of dormancy. But so far in 2016, those new drugs have hardly made…

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Top HF Expert Decries ‘Unbelievable Folly’ of Clinical Trials and Guidelines

–Milton Packer, MD, calls the system to test and evaluate heart failure drugs dysfunctional The system is completely broken, writes heart failure specialist Milton Packer, MD, in an editorial in Circulation: Heart Failure. The results of important clinical trials are not being incorporated into guidelines quickly, intelligently, or consistently, Packer argued. The most important reason…

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Deals Seek To Link Entresto Cost To Effectiveness

For two large insurance companies payment for the new heart failure drug Entresto will be linked to its health benefits. Both Cigna and Aetna have confirmed that they have reached a pay-for-performance deal with the drug’s manufacturer, Novartis. According to  a press release issued by Cigna, “the pay-for-performance agreement ties the financial terms to how…

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Entresto Maker In Deep Water Over Terrifying TV Advertisement

Updated with comments from Novartis and Mary Knudson– A Novartis television commercial and advertising campaign is terrifying millions of people and provoking sharp criticism from doctors. The critics include Milton Packer, a top expert who ran the main trial testing the company’s big new heart failure drug, Entresto. The ad depicts a middle-aged man in…

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Slow Start For ‘Blockbuster’ Heart Failure Drug Entresto

Entresto, the new heart failure drug from Novartis that is widely expected to be a blockbuster, is off to an exceptionally slow start. Approved last July, the drug, formerly known as LCZ 696, had sales of only $21 million in 2015, only $5 million of which came in the fourth quarter. Despite low expectations in the early…

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More Concerns Raised About Possible Risks Of New Heart Failure Drug

(Updated with an additional comment from Milton Packer) More safety concerns are being voiced about Entresto, the new, ballyhooed heart failure drug from Novartis.  Fueling these concerns is a mix of speculation, worry about the FDA’s rapid approval of the drug, and a long-running feud between two leading heart failure researchers. The concerns, raised in a JAMA Viewpoint by heart failure…

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PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years

Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it…

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Novartis Heart Failure Drug Gains Approval In Europe

Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). The news follows previous approval of the drug by…

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Slow Start For New Novartis Heart Failure Drug Entresto

Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be…

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Cost Effectiveness Of Entresto And CardioMEMS Evaluated

The new Novartis heart failure drug Entresto  (the combination of sacubitril and valsartan, formerly known as LCZ696) is cost effective but the CardioMEMS monitoring system (St. Jude Medical) is not, according to draft reports issued last week by the Institute for Clinical and Economic Review (ICER). The same organization released a widely discussed report about the cost…

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Novartis Heart Failure Drug Gains Speedy FDA Approval

Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived 6 weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.Novartis said the wholesale acquisition cost of Entresto will be $12.50 per day, less discounts….

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Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain. FDA approval of Entresto is expected…

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