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Dew, other than the JUPITER trial, are there any outcome trials that showed lower LDL reduce MACE? TIA.
ACCORD trial used fenofibrate, which raised HDL, lowered LDL and trig., failed its CVOT.
AIM-HIGH trial used extended release niacin, which raised HDL, lowered LDL and trig., failed its CVOT.
HPS2-THRIVE trial also used extended release niacin, which raised HDL, lowers LDL and trig., failed its CVOT.
JUPITER trial used Crestor, which lowered LDL, trig., inflammation markers and raised HDL modestly, succeeded in its CVOT.
Reduce-IT trial uses Vascepa, which lowers trig., inflammation markers and LDL (modestly) while being HDL neutral.
Eric Coleman called the failure of ACCORD, AIM-HIGH and HPS2-THRIVE trials "NEW" scientific evidence for rescinding ANCHOR SPA. First of all, the timing of those CVOT failures made those evidence "NEW" untrue. Second, Vascepa is not a HDL raising drug, so those "NEW" evidence shoudn't even be applied here. Lastly, since both Fenofibrates and Niacin also lower LDL, do all future LDL lowering therapies requires CVOT too. The answer is "NO", not according to the same Eric Coleman (e.g. his comments on PCSK9.) Why couldn't FDA and those PHD panel members look more closely at the success of JUPITER trial and draw a more favorable conclusion on the potential success of REDUCE-IT?
FDA could say PCSK9 is LDL lowering while Vascepa is trig. lowering, apples and oranges, not the same. We all know it's BS but that's the FDA stance in court, if come to that.
Coleman's argument is, at this moment, FDA does not require CVOT results for LDL lowering therapy. Vascepa, in the eyes of FDA, is only a trig. lowering agent. Due to the failure of AIM-HIGH, THRIVE, etc., FDA requires Reduce-IT to be completed before ANCHOR approval. I think this is all BS. The bottom line is Amarin is a small bio with no connection. FDA is more than willing to bend over backward to facilitate BPs and those companies it has connections with(e.g. VNDA). Coleman and Mary Parks are without conscience. Imagine how many MACE would have been prevented in next four years if ANCHOR is approved now.
Bio, thanks for the reply.
If statin is so bad, which I believe, Amarin should have 3 groups for Reduce-It : Placebo, Vascepa only and Vascepa+optimized statins to settle the score once and for all. I think Amarin was either not smart enough or afraid to piss off FDA and its BP friends when designing the Reduce-It trial design.
Vascepa cuts trig and reduce inflammation (for unknown reason, Amarin have not mentioned much about V's anti-inflammatory effect) while having a neutral effect on LDL, unlike Lovaza.
Guys, I have finally figured out the FDA with proof.
VNDA got a clean 10-0 sweep in its panel this afternoon. Why?
It's CMO worked at FDA first, quit and go back to FDA with tons of VNDA stock options. Check out his Linklin profile :
John Feeney, M.D.'s Experience
Clinical Team Leader, Analgesia Products
FDA
Government Agency; 5001-10,000 employees; Government Administration industry
September 2013 – Present (3 months)
Director
Feeney Consulting LLC
October 2012 – September 2013 (1 year)
Board-certified neurologist with both industry and FDA experience
Chief Medical Officer
Vanda Pharmaceuticals
Public Company; 11-50 employees; VNDA; Pharmaceuticals industry
January 2009 – September 2012 (3 years 9 months)
Deputy Director, Division of Neurology Products
FDA
Government Agency; 5001-10,000 employees; Government Administration industry
November 2006 – October 2007 (1 year)
Various, Division of Neurology Products
FDA
Government Agency; 5001-10,000 employees; Government Administration industry
January 1992 – November 2006 (14 years 11 months)
Neurology Consultant
National Naval Medical Center
April 1993 – July 2005 (12 years 4 months)
Eric Coleman said PCSK9 inhibitors will not need outcome study. Double standard?
http://www.bloomberg.com/news/2013-11-14/amgen-and-sanofi-pcsk9-drugs-can-reach-u-s-without-long-studies.html
Quest Diagnostic tests for AA/EPA ratio (see link) :
http://www.questdiagnostics.com/testcenter/BUOrderInfo.action?tc=17864&labCode=TMP
Seems like the new treatment guidelines force statins on more patients :
(CNN) -- If you're not on medicine to lower your cholesterol yet, you might be soon.
In what's being called a tectonic shift in the way doctors will treat high cholesterol, the American Heart Association and the American College of Cardiology on Tuesday released new treatment guidelines calling for a focus on risk factors rather than just cholesterol levels.
The new guidelines could double the amount of people on medication to lower their cholesterol, experts say.
"This is an enormous shift in policy as it relates to who should be treated for high levels of cholesterol," said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic.
The biggest change from the old guidelines, he says: Ignore the numbers.
Watch this video
Report: More Americans should take statins
Watch this video
Test your cholesterol knowledge
Watch this video
Know your cholesterol numbers
"For many years, the goal was to get the 'bad' cholesterol levels -- or LDL levels -- below 100," Nissen said. "Those targets have been completely eliminated in the new guidelines, and the threshold for treatment has been eliminated."
In their place, the guidelines suggest using specific risk factors to determine who should be treated with cholesterol-lowering statin drugs, and who should simply make lifestyle changes.
Among the four questions to ask to determine risks: Do you have heart disease? Do you have diabetes (Type 1 or 2)? Do you have a bad cholesterol level more than 190? And is your 10-year risk of a heart attack greater than 7.5%?
According to the new guidelines, if you answered yes to any of those four questions, you should be on a statin. Period.
New drugs could drop cholesterol to extreme lows
For those who do not fit those criteria, the committee behind the new policy says lifestyle and behavior management should be sufficient to help manage high cholesterol.
"The focus for years has been on getting the LDL low," said Dr. Neil Stone, committee chairman.
"Our guidelines are not against that. We're simply saying how you get the LDL low is important. Considering all the possible treatments, we recommend a heart-healthy lifestyle and statin therapy for the best chance of reducing your risk of stroke or heart attack in the next 10 years."
Calculating risks
So how do you and your doctor determine if your 10-year risk of a heart attack is above 7.5% and you should be put on a statin?
A simple calculation, said Dr. Donald Lloyd-Jones, chairman of the committee that developed the equation.
"We were able to generate very robust risk equations for both non-Hispanic white men and women as well as African-American men and women," Lloyd-Jones said. "Those equations factor in age, sex, race, total and HDL ('good') cholesterol levels, blood pressure levels, blood pressure treatment status as well as diabetes and current smoking status."
Each of those factors is assigned a numerical value and can be used to determine individual risk percentage using an online calculator.
The hope, Lloyd-Jones said, is that by doing these calculations, patients can be more informed about their risks when going to see doctors.
"The greatest strength behind these guidelines is that they hit at the heart of prevention -- which is that lifestyle, rather than treating isolated risk factors, is the key to reducing risk of chronic disease," said Dr. Sharon Horesh Bergquist, an assistant professor of medicine at Emory University, in an e-mail.
"We tend to focus on 'quick fix' answers such as a pill ... whereas the risk reduction from lifestyle changes, such (as) exercise three-four days a week, reduces risk nearly double to that from any one of the medication interventions."
Double the prescriptions
By changing the way doctors evaluate a patient for statin therapy, Nissen said these new guidelines will effectively double the number of Americans eligible for statin therapy, bringing the total to about 72 million.
How to boost your 'good' cholesterol
So does this mean big bucks for the pharmaceutical companies? Nissen said no -- and in fact, it may mean a downturn in their business.
"Now, except for Crestor, they're virtually all generic -- you can get a three-month supply for $10," he said. "So there's really no money to be made with statins anymore."
He goes on to say that while prescriptions for these drugs will increase dramatically, the guidelines all but shunned other cholesterol-lowering drugs such as Zetia, a big moneymaker for Merck & Co.
Aside from the financial aspects of medicating 35 million more Americans, using statins in a much broader population has been controversial.
Some people, such as cancer expert Dr. David Agus, advocate giving everyone older than 45 a statin, due both to cholesterol-lowering properties and potential benefit in reducing cancer.
Others say that with the potential side effects from statin use -- muscle pains and soreness, a potential moderate increase in liver disease and a risk for developing Type 2 diabetes -- they should be used with care.
Nissen, who strongly disagrees with Agus' suggestion on statins, said a measured approach is best.
"If you have a young woman who is otherwise healthy, giving (her) a statin doesn't make any sense at all," Nissen said. "I do believe the evidence is solid that if you have risk, that statins are enormously beneficial."
Other recommendations
In addition to the guidelines on evaluating cholesterol risk, the American Heart Association and American College of Cardiology released two other sets of guidelines relating to overall heart health.
One report gives guidelines for eating a heart-healthy diet, including reducing saturated and trans fats as well as limiting sodium to 2,400 milligrams per day -- 30% less than the average American consumes on a daily basis.
Cholesterol levels: What numbers should you aim for?
The other report dealt with treatment guidelines for physicians on managing weight loss in their patients. They include a call to create individualized weight loss plans and recommend counseling with a dietitian or other certified weight loss professional for at least six months.
That report also goes on to suggest that doctors should begin offering bariatric surgery as a potentially viable option to improve health for patients with a body mass index over 40, or those with a BMI over 35 and other complicating factors.
Management might possess some material non-public information such as BD or other partnering inform. That's the only reason I can think of for the lack of insider buying.
Amarin is saying if those scientific studies are such ground breaking, why did FDA even bother to enter a SPA with AZN for trig lowering.
Why didn't FDA rescind AZN's SPA as well? Double standard?
I think Amarin should stress that, in its concluding remark, it cost lots of money to run the CVOT, especially given its limited financial resources. However, in order to be able to serve an unmet medical need, the company is determined to see Reduce-It to conclusion using all means possible. Given Vascepa's proven safety & efficacy, its an educated gamble worth to take.
You can't ignore the possibility. BP might be afraid of the MACE reduction capability of Vascepa, which could be more powerful than Statins and other drugs in BP's pipeline. THe NCE delay might be explained by the same theory.
zum, don't forget the great dr. miller.
@green_day4me twitted the following :
"In recent EMDAC vote to require CVOTs 4 ob drugs Hiatt, Seely, Hendricks voted "no" citing it will limit innovation. All 3 r on $AMRN panel. The committee members who voted to require CVOTs recommended that they be conducted either post-approval or as a two-stage process "
I could be wrong but I didn't see Hendricks among the panel members.
Dew, always appreciate your insight. Hope the panel vote go at least as well as you expected. THX.
Guys, Red Acre discovered the following nugget in its twit @redacre :
$AMRN From: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
"It was agreed that a non-inferiority test for percent change from baseline in LDL-
C would be performed between AMR101 and placebo using a non-inferiority margin of 6% and a significance level at 0.05."
VS
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM370985.pdf
"The sponsor performed non-inferiority tests for percent change from baseline in LDL-C between each of the AMR101 doses and placebo using a non-inferiority (NI) margin of 6% and a 1-sided significance level of 0.025. This reviewer thinks that the non-inferiority test was not suitable in this setting [for an efficacy claim] because the study was a placebo-controlled trial."
Sorry FDA - you can't have it both ways - if you agree to it in the SPA - you cant change your mind later regarding whether or not the test is the right one.
A stupid question from me. Can FDA approve ANCHOR for diabetics only? Let diabetics patients and docs decide. Choose between CVD anytime or wait 3 years. James Gandofini might still be alive if Vascepa was available.
Anybody know how, on average, statistician & consumer rep vote in ADCOM? Have you ever seen a "runaway jury" type situation in ADCOM?
So you don't mind getting A-Fib and raised LDL to save a few bucks in copay?
terra, VC=EPA.
Dew, thanks for your insight. What's the 2 or 3 things that Amarin management must communicate @the ADCOM to ensure panel vote goes in their favor. TIA
Zum, great find. Can we say 1-0?
go_seek, how much does it cost? TIA.
yoyo, under your scenario #2, what about unnecessary and preventable death? Much more significant than egg in the face.
If FDA reject ANCHOR, does it mean it's OK not to treat patients with TG of say 350 or 450? The existing treatment options such as Lovaza, fibrates or Niacin just not getting the job done (with various side effects, etc.). Or FDA would rather encourage patients to get an off-lable script?
Zum, if the panel is all about science, the vote will be a 10-0 sweep. On the other hand, if the panel is just for show and are influenced by the Statin Gang, Steve Ketchum might as well pack his bag and go home.
Is the FDA going to be responsible for potential loss of life in next 3 years by delaying ANCHOR if CVOT proves successful come 2016?
Vascepa been on the market for 9 months already. Its efficacy and ability to reduce trig. has been tested in real life, mineral oil or not. So what's the big deal?
How do you know? Just your opinion I hope.
Study,
Thanks for the explanation. I got it now.
I thought NCE is given upon drug approval on PDUFA date rather than ADCOM date (because drug is not guaranteed to be approved even with a positive panel vote). If your theory is correct, Vascepa should get NCE end of the year.
Thanks to Dew D for posting info. on the ACCORD study yesterday.I extracted the following from the study :
"TriCor fared better in a subgroup of patients with a higher median triglyceride level of 284 and low HDL. Among those patients -- some 17 percent of participants -- the combination therapy led to about a 30-percent reduction in the risk of the composite goal of heart attack, stroke and cardiovascular death."
On Sep 25, 2013, Amarin has a press release regarding REDUCE-IT enrollment. I extracted the following from the press release :
"The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies. Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL. In addition, all patients enrolled in the study have either documented cardiovascular disease (CVD) or are at high-risk for CVD."
Intelligent investors can draw their own conclusions about the probability of success of REDUCE-IT.
Thanks Bio for the info. The panel vote for Invokana was 10-5 on efficacy and 8-7 on safety due to raised concerns about cardiovascular risks. FDA still approved the drug. Guess what the panel votes for Vascepa, which improves various bio-markers and cardiovascular health, will be.
Roger,
Congrats for the great numbers. You have found the holy grail of lipid management medications. If the ADCOM panel members saw your results, it'll be a 12-0 yes vote for ANCHOR indication. If Vascepa works as well for other patients, Amarin stock price will take care of itself no matter it's GIA, partnership or sell out. Congrats again.
Anna :
Your logic is correct. The worst case scenario for AMRN would be like what happen to HGSI. HGSI got a drug approval and decided to go it alone and stock languish at $7 level for a while. It then got a hostile offer from GSK at $13. After some back and forth negotiation, HGSI was finally taken over @$14.25.
K,
How many pills are there in your $19.99 bottle? What's the ingredient in each pill, i.e., EPA, DHA content, etc.? Or just tell me the brand, I'll look it up. TIA.