Novartis HF drug will sink Ivabradine...Run from CV

What is the status of ivabradine in Canada?

 

Wreka at al will sink Ivabradine...Run from CV

Isma B, safety regulatory and wrecka will be epic failure

 

http://www.sfgate.com/health/article/Congestive-heart-failure-and-what-to-do-about-it-6163822.php

More recently, there have been encouraging results from a new investigational medication that has shown to be more effective in preventing death and hospitalizations in patients with congestive heart failure. LCZ696 combines two blood pressure drugs - an angiotensin II receptor blocker and the neprilysin inhibitor known as sacubitril. If approved by the Food and Drug Administration, this drug will help improve the outcomes of millions of Americans.


NO ONE EVER MENTIONS IVABRADINE BECAUSE IT'S A PIECE OF $H!t

 

Why are you starting the obvious? Corlanor will be a multi-million dollar drug while LCZ696 will be a blockbuster drug.

 

Yes 2 million in sales or 100 pts is multi million dipshit

 

I can care less. I did not make this poor decision. Lol! Why are you so angry, we are getting paid!

 

OH, you can care less?...well hey, at least you care some.

 

http://www.nytimes.com/2015/04/16/business/fda-approves-amgen-drug-to-treat-heart-failure.html?_r=0

The Food and Drug Administration on Wednesday approved a drug to treat chronic heart failure that may help keep patients out of the hospital.

The drug, which Amgen will sell under the name Corlanor, works by slowing the heart rate, which helps relieve stress on the organ. Amgen licensed the American rights to the drug, known generically as ivabradine, from the French company Servier, which has been selling it in Europe for about a decade.

Many Wall Street analysts and heart failure specialists are lukewarm about the drug, which has had mixed results in clinical trials. They are more excited about a heart failure drug from Novartis, called LCZ696, which could be approved by August.

Amgen’s drug will be for “a niche of patients, potentially small, compared to a full cohort of patients who will be immediate candidates for LCZ696,” Dr. Clyde W. Yancy, chief of the cardiology division at the Feinberg School of Medicine at Northwestern University, wrote in an email.


Still, the approval moves Amgen into the cardiology drug business, preparing it for the expected approval this summer of a much more important cardiovascular drug — a powerful cholesterol fighter called evolocumab.

More than five million Americans suffer from heart failure, in which the heart does not pump blood adequately, a condition that can result from a heart attack or other causes. Heart failure is a leading cause of hospitalizations.

People with heart failure now take various drugs, including beta blockers, which work partly by slowing down the heart beat. Corlanor is approved for patients whose resting heart rate is still above 70 beats a minute — considered high enough to strain the heart — despite taking the highest dose of beta blockers they can tolerate. Dr. Sean E. Harper, executive vice president for research and development at Amgen, said about one million Americans fit that description.

Amgen will charge $375 a month, or about $4,500 a year, for Corlanor, which could be a challenge because most other drugs used for heart failure are relatively low-cost generics. But Dr. Harper said the drug could save the health care system money by reducing hospitalizations.

“It’s an unusual circumstance where the impact of the product is so tangibly calculable,” he said.

He said Corlanor, a pill taken twice a day, represents the first new type of drug for heart failure that has been approved in about a decade. The drug works by inhibiting what is known as the “funny current” in the heart’s natural pacemaker.

Amgen won approval based on a trial sponsored by Servier that involved more than 6,500 patients with moderate to severe heart failure and heart rates over 70 beats a minute. They were randomly assigned to take either ivabradine or a placebo, in addition to their existing medications.

After nearly two years, 16 percent of patients receiving ivabradine were hospitalized for worsening heart failure compared with 21 percent of those getting the placebo. That represented a reduction in risk of 26 percent by a measure known as the hazard ratio. The drug also reduced deaths from heart failure but not deaths from all cardiovascular causes, according to the results published in The Lancet in 2010.

Dr. Yancy said the results of the trial, which was conducted from 2006 to 2009 outside the United States, might not fully apply to American patients treated with the most modern methods.

There have been other studies, albeit in different patient populations, in which the drug did not work as well. The European Medicines Agency said last year that in certain patients with angina, which is chest pain from insufficient blood flow to the heart, the drug might actually increase the risk of heart attacks and deaths from cardiovascular causes. The drug can also cause heart rates to drop dangerously low in some patients.


Sounds like a very niche drug that doctors will only prescribe to a few pts....

 

Our drug should not and can't compete with LCZ!! Why are we even trying. Do you know how many CV thought leaders are backing LCZ?! A ton!! It's a blockbuster. We aren't even in the same game. We fail completely if we try to compete with this. Seriously? Placebo in our studies and our efficacy is still questionable. Give me a break.

 

I launched 3 Blockbusters at Novartis; Zelonorm, Tekturna, and Reclast. Sadly none of the hype lasted past the PDUFA date. Z is off the market, T should be off the market and R, well let's just say Novartis doesn't know how to launch products well. Even if they are in a class by themselves and have superior head to head data, Nov just doesn't have the know how. Just plain fact.

 

I worked for novartis as well. I agree. But this drug LCZ Has the data and experts behind it. It's going to be different. Just saying.

 

Zelnorm was one of the best drugs ever!!! I'm not kidding.

 

Novartis might suck, but this drug will sell itself. The data package and KOL support will make it a blockbuster. Even the shitty pushy reps who get kicked out of offices will still sell well.

 

"Dr. Clyde W. Yancy, chief of the cardiology division at the Feinberg School of Medicine at Northwestern University, tells the New York Times that Amgen's drug will likely play second fiddle to Novartis's LCZ696, a major blockbuster contender which is expected to be approved soon. Corlanor, he says, will be reserved for "a niche of patients, potentially small, compared to a full cohort of patients who will be immediate candidates for LCZ696."

Sorry Amgen. Trying to create competition against LCZ is over!!!! And what desperate dumb losers we look like of we try! No competition. They destroy us.

 

I am a CV DM and any one of my reps or any rep that says LCZ696 is better will be fired by me! Learn to sell you maggots. It's what we pay you lots of money to do, not complain.

Want to get RIFed like those loser Onyx reps and DMs?

 

I am a CV DM as well and I concur. Corlanor will hit $2.5B or I am looking for ways to fire my reps or demote them to the CSO.

If they can't hang, I'll let them dry and DIE!!! Sell bitches sell!!!

 

So this drug known as Procoralan in Europe; costs about $3.00 USD per day in France. Or about $90USD per month. And has been available on market since 2006.

Amgen is launching at a US price of $375 per month or $12.50 per day. And did absolutely no clinical study or research investments for FDA.
WTF - unless the goal is to simply piss off every insurance company, PBM and health plan possible.

Good luck.......

 

Amgen - yesterday's drugs at tomorrow's prices.

 

Bring it on Novartis !!

 

IVA TOOO WILL BE A MEGABUSTER!!!! YEEEE HAW BABY!!! RIDEM

Readying itself for what looks like a blockbuster victory lap in the cardiovascular field, Novartis ($NVS) has notched boasting rights for its heart drug LCZ696, gaining recognition in the U.K. as a "promising innovative medicine" that could be made available to patients ahead of formal marketing approval.


The Medicines and Healthcare products Regulatory Agency, or MHRA, granted the designation earlier today as an opening move toward early access. And they were moved by the PARADIGM-HF Phase III study, which demonstrated some clear benefits in reducing cardio deaths.

The MHRA isn't going to get any kickback from Novartis. Novartis pharma chief David Epstein has already dubbed this drug a "megablockbuster" in the making. And Thomson Reuters just days ago estimated 2019 sales for this drug at $3.73 billion.

The stellar data and a breakthrough reputation on both sides of the Atlantic helped chill expectations for Amgen's ($AMGN) newly approved heart treatment Corlanor (ivabradine). Even some concerns about a potential link to Alzheimer's--recently outlined by French researchers--has barely shaken the faith for LCZ696.

Last month the MHRA selected Merck's Keytruda, the closely-watched PD-1 checkpoint inhibitor, as the pioneer therapy to win early market access in the U.K. Northwest Biotherapeutics ($NWBO), meanwhile, won the first PIM last fall for its cancer vaccine DCVax.

"Despite widespread use of available treatments and implementation of NICE heart failure guidelines, outcomes remain poor for those diagnosed, with around 60% dying from heart failure within five years," says Hugh O'Dowd, the general manager at Novartis UK & Ireland. "It is therefore very encouraging that LCZ696 has been recognised as a scientific innovation that can improve the lives of people living with this debilitating condition."