Will Brilinta Be Approved Next Week or Not?

[Anonymous]

Stemi's are a small percentage of the total cath's and effient is far superior to plavix in the diabetes patient and stemi based on efficacy, onset of action and the fact no non responders in the loading phase and very very very few in the maintenence phase. Effient is recommended as well, this person left that out.

Now as for Brillinta, there just is no place for it. Hospitals reimbursement cuts and challenges with cost will make it impossible for them to use this first line on all patients. It will not happen. They will start to genetic test patients to see if allergic to plavix or are non responders. If they are then yes Brillinta and or Effient will be used. In the Er Brillinta will make the better choice due to 2-3 days reversing period vs 5-7 days for effient. So that will be the window. In the cath lab once the see the anatomy, Effient clearly is the best choice, since reversing or the 2-3 day period of reversing vs Effient's period is irrelevant now as they now can see if there will be a need for a possible Cabg.

Once they leave the hospital, Brillinta will never be used two reasons

cost vs a generic (keep in mind this is not the only drug these patients pay for, they generally take 15-25 other pills, so this co-pay difference will be huge on physicians minds. It already is. Just look at the period of time with Plavix went generic for a short while what happened).

Brillinta is 2 pills per day and the risk if the patient does not take the recommended dose is severe.

Also, it truly is not a benefit to the patient to re-anticoagulate their body 2 times, this is extremely dangerous increases stroke risk and dangers to cardiac system in general. So I would be very careful marketing to thought leaders about the reversability of this drug, it should be a last ditch thing that you point out just in case, and then contrast and compare the data and the impacts of increased bleeding the happens from a patient going to CABG.

This drug simply just like effient, simply came along too late. Plavix may not be the best option, but it is THE option that Cardiologist were trained with, are comfortable with, and do not have to think through. Plus it will be a cost saviings to hospitals and to patients in the 1st quarter of 2012.

Only advantage is that there will not be plavix reps out counter detailing once it goes generic.

You forgot one thing ......the survival rates are much much much much better... healthcare may be cold business but less people dying is good thing.

 

[Anonymous]

is it approved or not? really someone has to know!

 

[Anonymous]

Also, The drug, which has been approved by European regulators, could bring in about $2 billion by 2016. But while proving generally more effective in studies than Plavix -- another blood thinner, and the world's second-best selling drug -- Brilinta did not appear to offer an equal benefit in U.S. patients. That has some analysts cautioning that its approval is not a sure thing.

"We see a number of significant issues that we do not believe the FDA has enough comfort on to issue a strong label for the product, if at all," Jefferies analyst Jeffrey Holford wrote in a Dec. 9 note.


I would place a bet on it's getting approved, let alone a decent label where we can actually promote it. Enjoy this Christmas my friends, for certainly next year your bucket of coal will be a quite bit lighter. That is unless you are David Brennan of course!

Effient is a better drug and it only has 3% of the market after 18 months.....Plavix is effective and safe, Dr's love it....generic clopidigrel will be it's swan song......

 

[Anonymous]

It did not get approved. Complete Letter of Response asking for further analysis.

 

[Anonymous]

aaaaaaaaaaaaaaaaaaaaawwwwwwwwwwwwwwwww

 

[Anonymous]

The comments on Brilinta are interesting. The Effient market is only about 30% that of Plavix so a 3% share is not a bad starting point. Plavix generic is already in Europe and has about 50% of the market but Effient appears to have the bulk of the STEMI market. With data showing Brilinta is less effective in diabetes and STEMI (with a 63% increased stroke risk) than Effient where will they niche the market. NSTEMI? Ok it is more effective that plavix but in Europe has a 14% price premium over Effient! Are bean counters going to go for the costly option at £55 which saves a few people or take the risk with the one which costs £4 and treat those that re-event? And they say that drug companies are heartless beasts!

 

[Anonymous]

.AstraZeneca Plc told the U.S. Food and Drug Administration that high-dose aspirin most likely caused different results in a test of the Brilinta blood thinner, citing an analysis requested by the regulator.

The FDA will now decide whether AstraZeneca’s response on the drug, also known as ticagrelor, is complete and whether to start a two-month or six-month review, the London-based company said in a statement today. The company is seeking approval to sell Brilinta as a treatment to prevent artery-blocking clots that can cause heart attacks and severe chest pain.

The FDA last month asked for additional analysis of a study called Plato comparing Brilinta with the Plavix blood thinner. The twice-daily pill won a 7-1 recommendation from an FDA advisory panel on July 28. All committee members had expressed concern that study participants in the U.S. and Canada did worse on Brilinta than people in other parts of the world. Many North American patients were also receiving high-dose aspirin, AstraZeneca said.

“AstraZeneca remains of the view that either the play of chance or an interaction between high-dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of U.S. patients in the Plato trial,” the drugmaker said today.

The shares gained 41 pence, or 1.4 percent, to 2,963.5 pence in London trading.

Aspirin Theory

FDA staff in July rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome. The agency noted that rates of bleeding, a potentially serious side effect, were higher immediately after patients received Brilinta, before there would have been a chance for interaction with aspirin, than they were with Plavix, said Jeffrey Holford, an analyst at Jefferies International Ltd. in London.

The company’s statement “does not sound as if the re- analyses provide absolute clarity on the issue,” Holford, who rates the shares a “hold,” wrote in a note to clients today. “The FDA may feel that it needs to request an additional trial.”

The FDA’s decision delayed a product whose sales may have reached $2.5 billion by 2016, according to the average estimate of three analysts surveyed by Bloomberg. It aims to take on the world’s second-best selling drug Plavix, from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA.

AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.

 

[Anonymous]

"pharmaceutical sales layoffs how to survive" under Goo gle

 

[Anonymous]

.AstraZeneca Plc told the U.S. Food and Drug Administration that high-dose aspirin most likely caused different results in a test of the Brilinta blood thinner, citing an analysis requested by the regulator.

The FDA will now decide whether AstraZeneca’s response on the drug, also known as ticagrelor, is complete and whether to start a two-month or six-month review, the London-based company said in a statement today. The company is seeking approval to sell Brilinta as a treatment to prevent artery-blocking clots that can cause heart attacks and severe chest pain.

The FDA last month asked for additional analysis of a study called Plato comparing Brilinta with the Plavix blood thinner. The twice-daily pill won a 7-1 recommendation from an FDA advisory panel on July 28. All committee members had expressed concern that study participants in the U.S. and Canada did worse on Brilinta than people in other parts of the world. Many North American patients were also receiving high-dose aspirin, AstraZeneca said.

“AstraZeneca remains of the view that either the play of chance or an interaction between high-dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of U.S. patients in the Plato trial,” the drugmaker said today.

The shares gained 41 pence, or 1.4 percent, to 2,963.5 pence in London trading.

Aspirin Theory

FDA STAFF IN JULY REJECTED ASTRAZENECA’S SUGGESTION THAT HIGHER U.S. ASPIRIN USE CONTRIBUTED TO THE OUTCOME. THE AGENCY NOTED THAT RATES OF BLEEDING, A POTENTIALLY SERIOUS SIDE EFFECT, WERE HIGHER IMMEDIATELY AFTER PATIENTS RECEIVED BRILINTA, BEFORE THERE WOULD HAVE BEEN A CHANCE FOR INTERACTION WITH ASPIRIN, THAN THEY WERE WITH PLAVIX, SAID JEFFREY HOLFORD, AN ANALYST AT JEFFERIES INTERNATIONAL LTD. IN LONDON.

The company’s statement “does not sound as if the re- analyses provide absolute clarity on the issue,” Holford, who rates the shares a “hold,” wrote in a note to clients today. “The FDA may feel that it needs to request an additional trial.”

The FDA’s decision delayed a product whose sales may have reached $2.5 billion by 2016, according to the average estimate of three analysts surveyed by Bloomberg. It aims to take on the world’s second-best selling drug Plavix, from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA.

AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.

Well, well, well. Looks like we gave them the same info we did months ago. Maybe if they used a TSi type presentation they would have made a better impression on the FDA!!

 

[Anonymous]

Well, well, well. Looks like we gave them the same info we did months ago. Maybe if they used a TSi type presentation they would have made a better impression on the FDA!!

What's happening? Those responsible have gone to the FDA at least 3x. Haven't they uncovered and sold to the need by now! They should have solidified their relationship and earned the right to close. Didn't they follow the metrics? Somebodies going to be at the bottom of the tier.

 

[Anonymous]

What's happening? Those responsible have gone to the FDA at least 3x. Haven't they uncovered and sold to the need by now! They should have solidified their relationship and earned the right to close. Didn't they follow the metrics? Somebodies going to be at the bottom of the tier.

You're forgetting that the people making the rules here don't have to abide by any rules! It's a boys club! The shareholders, lower level employees, patients, FDA -- no one tells AZ execs what to do, don't you understand?

 

[Anonymous]

Why isn't the BOD asking for high level resignations? Seriously, most of the people at the top ran over people treating them like dirt to get to where they are. Time to pay the piper.

 

[Anonymous]

.“AstraZeneca remains of the view that either the play of chance or an interaction between high-dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of U.S. patients in the Plato trial,” the drugmaker said today.

Whew. Thought there was a need for concern there for a minute. That should be enough to convince 'em.

 

[Anonymous]

Maybe I am not so intelligent, but if they didn't accept that the first time. What makes AZ think they would a second time!!! And how much are these people getting paid!

 

[Anonymous]

I think we can all kiss Brilinta goodbye. These idiots have once again screwed up another product! I think the Board of Directors at AZ all must be on crack to let these morons continue to run the company!

 

[Anonymous]

I think we can all kiss Brilinta goodbye. These idiots have once again screwed up another product! I think the Board of Directors at AZ all must be on crack to let these morons continue to run the company!

If that happens, say good-bye to CVAS & Hospital

 

[Anonymous]

the FDA could care less if thdey ever approve an AZ product. AZ arrogance with the FDA along with bonehead science has gotten AZ what it deserves. AZ bit the hand that feeds it (the FDA) and is once again clueless as to why it is going nowhere.

 

[Anonymous]

Let's just hope someone at the FDA reads Cafepharma. AZ is in the process of explaining away a trend towards a worse outcome in some of the patients -- something to do with aspirin. Anyway, AZ is so much in the habit of lying about important thing like:

Product safety (Seroquel)
Culpability in lawsuits
Employee's careers and false terminations
"Patient Health First"

That the AZ company officials have zero credibility. It's bucks for the executives first, middle, and last. Let the world have its generic Plavix. Approve a better product if one comes along, not a worse one so that the patient can sign a disclaimer and maybe if the AZ rep is sweet on the doctor, your Mom will end up dying younger than need be, and AZ can sell a little pill that costs less than a penny to manufacture in quantity for around $5.00 each.

 

[Anonymous]

Let's just hope someone at the FDA reads Cafepharma. AZ is in the process of explaining away a trend towards a worse outcome in some of the patients -- something to do with aspirin. Anyway, AZ is so much in the habit of lying about important thing like:

Product safety (Seroquel)
Culpability in lawsuits
Employee's careers and false terminations
"Patient Health First"

That the AZ company officials have zero credibility. It's bucks for the executives first, middle, and last. Let the world have its generic Plavix. Approve a better product if one comes along, not a worse one so that the patient can sign a disclaimer and maybe if the AZ rep is sweet on the doctor, your Mom will end up dying younger than need be, and AZ can sell a little pill that costs less than a penny to manufacture in quantity for around $5.00 each.

what are you? A communist?

See the liability they have. One or two pogroms will show you the free enterprise system.

Why don't you just jump off a bridge?

 

[Anonymous]

what are you? A communist?

See the liability they have. One or two pogroms will show you the free enterprise system.

Why don't you just jump off a bridge?

Your post doesn't make any sense.

As for my political slant, I am a free enterprise capitalist. That's why I don't like the way pharmaceuticals are sold -- under government protection, selected by people who aren't buying or using the product.

In no other system other than the US's would we have a company trying to push an inferior product like Brillanta. They know if they get approval (protection) from our government, they'll be able to make money on the product, despite the fact that it is inferior and has safety concerns. The problem is there is no ceiling on the price they can charge -- no free market competition keeping prices down.