(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…
ATMOSPHERE: Heart Failure Trial Poisoned By Controversy
April 4, 2016 by 1 Comment
–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed…
US DOJ Expands Investigation Into Phony Novartis Speaking Events
March 29, 2016 by 1 Comment
— The government wants Novartis to turn over documents on 80,000 separate speaking events. The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.” Last week the DOJ…
Deals Seek To Link Entresto Cost To Effectiveness
February 9, 2016 by Leave a Comment
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…
Entresto Maker In Deep Water Over Terrifying TV Advertisement
February 2, 2016 by 21 Comments
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…
Novartis Heart Failure Drug Gains Approval In Europe
November 24, 2015 by Leave a Comment
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…
Slow Start For New Novartis Heart Failure Drug Entresto
November 2, 2015 by 1 Comment
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…
ESC 2015 Set To Start In London
August 28, 2015 by Leave a Comment
The European Society of Cardiology meeting starts this weekend in London. Merrie Olde Englande? Industry will be here too. …
Novartis Heart Failure Drug Gains Speedy FDA Approval
July 7, 2015 by Leave a Comment
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….
Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel
May 22, 2015 by Leave a Comment
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…
New Heart Drug From Novartis: Will It Raise The Risk of Alzheimer’s Disease?
February 9, 2015 by Leave a Comment
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…
An Emerging Consensus About Novartis’s New Potential Blockbuster
January 7, 2015 by Leave a Comment
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…
PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment
August 30, 2014 by Leave a Comment
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…
Predicting PARADIGM-HF, Or What To Expect When You’re Expecting
August 27, 2014 by Leave a Comment
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…
FDA Rejects Novel Novartis Drug For Acute Heart Failure
May 16, 2014 by Leave a Comment
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…
A New Novartis Heart Failure Drug Might Be A Blockbuster
April 1, 2014 by Leave a Comment
I try to avoid using words like “blockbuster” and “breakthrough” when writing about new drugs and treatments. I’ve been disappointed too many times. But, though they’ve been in short supply lately in cardiovascular medicine, sometimes there really are breakthroughs and blockbusters. In my career writing about cardiovascular medicine I’ve seen the introduction of the ACE…
Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality
March 31, 2014 by 1 Comment
The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s two primary investigators. Earlier today I reported that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early because the trial had demonstrated…
Early Success For Novel Novartis Heart Failure Drug
March 31, 2014 by Leave a Comment
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and…
FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug
March 27, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last…
FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
March 25, 2014 by 1 Comment
Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday the FDA’s Cardiovascular and Renal Drugs…
European Setback For Novartis Heart Failure Drug
January 24, 2014 by Leave a Comment
European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which…
FDA Advisory Panel To Review New Heart Failure Drug From Novartis
January 7, 2014 by Leave a Comment
A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the…
Saying Sorry May Not Be Good Enough For Novartis
September 27, 2013 by Leave a Comment
Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company’s role in the scandal. If necessary, ministry officials are prepared to raid the company’s offices in Japan. A Novartis…
Lancet Formally Retracts Jikei Heart Study Of Valsartan
September 5, 2013 by Leave a Comment
The Lancet has formally retracted the Jikei Heart Study paper, originally published in 2007. The retraction had been widely anticipated for more than a month, after a series of news reports in Japan made it clear that the long-simmering controversy over scientific misconduct involving the Novartis blood pressure lowering drug valsartan (Diovan) had come to a full boil. (See our earlier story here.)…
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