Novartis Heart Failure Drug Gains Speedy FDA Approval

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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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200-Year-Old Heart Drug Linked To Increased Risk Of Death

For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin.  Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there…

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FDA Approves Amgen Heart Failure Drug

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes.    …

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New Heart Drug From Novartis: Will It Raise The Risk of Alzheimer’s Disease?

LCZ696 is a heart failure drug from Novartis that many observers think will gain FDA approval later this year and go on to become a blockbuster. Perhaps the biggest obstacle to the drug’s success is the fear that it might raise the risk of Alzheimer’s disease. Now a new article in a top cardiology journal lays out the detailed basis for…

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FDA Approves New Heart Pump From Abiomed

Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival…

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An Emerging Consensus About Novartis’s New Potential Blockbuster

Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in…

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Cardiology Drugs Of The Year: New, Old, And Not-So-Funny

New Drug Of The Year: LCZ696 from Novartis Old Drug of the Year: Ezetimibe Not-So-Funny Drug of the Year: Ivabradine … Click here to read the full post on Forbes.  …

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European Review Confirms Increased Risk with Ivabradine

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for…

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SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart…

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Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon….

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PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment

So far as I can tell the only problem with PARADIGM-HF is that the results are so good that it’s boring. Anyone interested can reasonably assume that what they hear or read about PARADIGM-HF — and cardiologists will be seeing and hearing an awful lot about it —  will be overwhelmingly positive. Briefly, the trial did…

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Predicting PARADIGM-HF, Or What To Expect When You’re Expecting

The wait is almost over. For the last 5 months the most eagerly awaited trial in the cardiovascular universe has been PARADIGM-HF, the large (8,500 patient) trial of a new and novel heart failure drug from Novartis. If reality lives up to the early hope and hype, the drug, LCZ696, could completely reshape the heart failure landscape…

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Study Offers Little Support for an Old Drug

Digoxin is one of the oldest drugs in the cardiovascular arsenal, derived from the foxglove plant and first described in the 18th century by William Withering. It is frequently used in patients with heart failure (HF) and with atrial fibrillation (AF). The few trials supporting its use were performed in HF patients before newer treatments…

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Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful

Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the   principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still…

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Januvia Linked To Increase in Heart Failure Hospitalizations

The cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy for many years now. More recently, attention has started to focus specifically on the risk for heart failure. Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck). In a…

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ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug

The first real details about the much-anticipated novel new heart failure drug from Novartis will kick off this year’s Hot Line sessions at the annual meeting of the European Society of Cardiology in Barcelona, Spain. The meeting runs from August 30 until September 3. As I have previously reported, the PARADIGM-HF trial was stopped because of a highly statistically significant reduction…

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Positive Results For New Oral Drug From Actelion

Actelion has announced positive top-line results for a phase III trial of a new oral drug for the treatment of pulmonary arterial hypertension (PAH). The drug, selexipag, is a first-in-class orally available selective prostacyclin IP receptor agonist. The pivotal, double-blind GRIPHON study was the largest outcome trial ever performed in PAH. 1,156 PAH patients were randomized to selexipag or placebo. The company said…

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Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug

There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the US, where it is under development by Amgen. Although it hasn’t been widely noticed– I can find no other…

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Prophylactic ICDs Appear Effective In Less Severe HF Patients

ICDs are routinely implanted in heart failure patients with ejection fractions (EFs) of 35% and lower to prevent sudden cardiac death. However, the benefits in patients at the higher end of the spectrum– between 30% and 35%– have not been well demonstrated in clinical trials, since few patients in this range have been enrolled in…

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FDA Approves Novel Implanted Sensor To Monitor Heart Failure

The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of  NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted…

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FDA Rejects Novel Novartis Drug For Acute Heart Failure

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. … Click here to read the full post…

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Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall?

For more than a decade cardiac stem cell therapy has attracted an enormous amount of attention, promise, and research dollars. Now an original and important new study published in BMJ finds that many of the most promising results in the field are illusory and that the potential benefits of stem cells to treat heart disease are probably far…

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FDA Grants Fast Track Status To Amgen Heart Failure Drug

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an umet medical need, will aid the development and speed the review of the drug. … Click here to read the…

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Troubled NHLBI TOPCAT Trial Disappoints

Although a significant portion of people with heart failure have preserved ejection fraction, none of the proven heart failure therapies has been shown to be beneficial in this important and growing heart failure subpopulation. Now a new NHLBI-funded study has failed to find a benefit in this group for spironolactone, which is a cornerstone of…

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