Well full disclosure ...I thought 70/30 in favor of approval at Adcom ...based on risk / benefit analysis ....potential for benefit with almost 0 risk .....so I was wrong there.
If expanded label ... An immediate jump to at least 3 ....then the debate will begin on whether or not the Corscia group might convert some of their debt to equity which might involve diluting the stock ...
I'm also wondering if the FDA may loosen their language on all RX fish oils ....so we might see more competition from generic Lovaza.
Let me try with common sense:
without a big jump, the first step: breaking out of $2.86;
the second step: $5;
and the third step: $7.
To break $7, additional power from scripts is needed.
I try an answer to that
Did not pay for doctor visit ....he emailed in request
Blood draw did cost me about $30
No charge for lipid panel ....guess my insurance covers that.
No doctor visit following ...email discussion on results / review ....no cost.
Yes , did get a prescription
Do not have extremely high TGs but do have a lipid disorder and a family history of heart disease .....so on risk reward basis Cardiologist felt it was worth trying
IMHO ...Amarin will finish RI no matter what
They currently have funds to last to early 2016 when an interim analysis is expected .
I expect Vascepa's label to be expanded to include language that states that CV risk may be reduced by lowering high TG's using Vascepa in patients at high risk .
Wider approval contingent on positive Reduce It read put.
The reason for the change ....recent research in the New England Journal of Med identifying high TG's as a risk factor ....And .....probably over 30,000 patients now on V for over a year and no adverse events
What insurance coverage do you have ?
Are you using Amarins coupon
What's your actual monthly cost ?
Agree that your MD will want the quantity and quality of EPA to be consistent especially at 4 gm dose and if you are considered high risk .....what's your lipid panel numbers and family CV history
Build a home
I agree that OmegiaVia Via EPA is the best alternative for those that can't get insurance coverage for Vascepa .
Some patients using insurance co pays and Amarins coupon get a months supply of Vascepa for $19 ...OmegiaVia EPA will cost about $34 from Amazon including shipping for a months supply ....since it's 88% EPA you will actually need more of it to equal daily dose of Vascepa ....
OmegiaVia Via EPA is regulated as a food ...Vascepa as a drug ...Quality and quantity of EPA is higher in Vascepa
If you are getting OmegiaVia EPA delivered you will need to watch delivery times as the last thing you want is for it left out in the sun all afternoon . Vascepa I get from cold storage at Walgreens
Bottom line ....If you have great insurance copay and Amarins coupon you don't even consider dietary supplement alternative .
If your insurance declines coverage ...OmegiaVia EPA ..provides a lower cost , lower quality alternative
Omega 3's are good for many things. Both EPA and DHA benefit humans and that is why your doctor will tell you to eat a lot of fish that is high in Omega 3's. It is the absolute best way to get your Omega 3's. Maybe the poor guy is depressed? You can address:
When taking Omega 3's.
Fish/fish oil contains the omega-3 fatty acids, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are the essential fatty acids that the typical diet is nearly ALWAYS greatly lacking. So eat well my friend. Eat healthy.
Fish allergies would be caused by any fish oil capsule. Most people get their EPA from unregulated food suppliers. If you want to take a fish oil supplement, Omegavia and Vascepa are the highest quality, pharmaceutical grade and are manufactured in plants audited by the FDA. I don't know about other brands, but for omega 3 capsules that only contain EPA, Omegavia and Vascepa are perfect. You just need to take 4 large Vascepa capsules or 8 tiny Omegavia capsules to equal 4 gms daily. Omegavia also offers the 4 gm dose in 4 large capsules, but you will never go back to those huge capsules once you have tried the tiny Omegavia capsules.
You won't get a rash unless you are allergic and if you are allergic, you shouldn't be taking fish oil supplements.
In Lovaza's labeling (Prescribing Information -- PI):
"1 INDICATIONS AND USAGE
LOVAZA® (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce
triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet
before receiving LOVAZA and should continue this diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are consistently
abnormal before instituting LOVAZA therapy. Every attempt should be made to control serum
lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical
problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid
abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers,
thiazides, estrogens) should be discontinued or changed if possible prior to consideration of
triglyceride-lowering drug therapy.
Limitations of Use:
The effect of LOVAZA on the risk for pancreatitis in patients with severe
hypertriglyceridemia has not been determined.
The effect of LOVAZA on cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined."
"14.2 Other Clinical Experience
The effects of LOVAZA 4 grams per day as add-on therapy to treatment with simvastatin
were evaluated in a randomized, placebo-controlled, double-blind, parallel-group study of 254
adult patients (122 on LOVAZA and 132 on placebo) with persistent high triglycerides (200 to
499 mg/dL) despite simvastatin therapy. Patients were treated with open-label simvastatin 40 mg
per day for 8 weeks prior to randomization to control their LDL-C to no greater than 10% above
NCEP ATP III goal and remained on this dose throughout the study. Following 8 weeks of openlabel
treatment with simvastatin, patients were randomized to either LOVAZA 4 grams per day
or placebo for an additional 8 weeks with simvastatin co-therapy. The median baseline
triglyceride and LDL-C levels in these patients were 268 mg/dL and 89 mg/dL, respectively.
Median baseline non-HDL-C and HDL-C levels were 138 mg/dL and 45 mg/dL, respectively.
The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA
plus simvastatin or placebo plus simvastatin are shown in Table 3.
Table 3. Response to the Addition of LOVAZA 4 grams per day to Ongoing Simvastatin
40 mg per day Therapy in Patients with High Triglycerides (200 to 499 mg/dL)
LOVAZA + Simvastatin
N = 122
Placebo + Simvastatin
N = 132 Difference P-Value
BL EOT Median %
BL EOT Median %
Non-HDL-C 137 123 -9.0 141 134 -2.2 -6.8
Vascepa, Lovaza, PlusEPA, Omegavia, Epanova and Omtryg are all rx quality omega 3 and will do what you need.
If you suffer from the extremely rare combination of high ldl and extremely high trigs, you should stick to EPA only supplements like Vascepa, PlusEPA and Omegavia. Humans need DHA but you might try to control your intake a little since DHA might cause LDL to go up. I know a ton of other things have DHA and a whole bunch of other things you are eating will cause your LDL to go up, but you need to stop eating them as well. Omega 3 capsules with DHA will be the smallest amount of DHA in your diet, but if you can avoid it, you should try. And then avoid all the other DHA in your diet and all the other foods that increase your LDL directly. They are far worse.
Vascepa, Lovaza, PlusEPA, Omegavia, Epanova and Omtryg are not a dirty leftovers. You think all fish oil is bad, but many are made in fda supervised plants. The brands listed here are all made in fda audited sites. Manufactured to highest GMP standard. Fish oil made in rx quality is not the same as all of the other fish oil that is made in regular plants. Those plants are not supervised like the rx grade plants. They are more like food processors, safe to eat but not as highly regulated. The food you eat every single day is made in far dirtier places than even the ordinary fish oil capsules, so you aren't really worried about the right thing anyway. Get your head on straight and try to take some science classes.
How much did you pay for the doctor visit? What about the visit for the blood draw? How much was your blood draw? How much was your blood test? How much was your lipid panel? How much did your next visit to your doctor cost? Did you review your blood test and lipid panel? Did you get your prescription then?
Did your Dr decide to write the prescription for you even though you are not suffering from Hyperlipidemia? How much did the Vascepa cost you for one month supply? Thank you for sharing.
Sorry you have no insurance and have to pay for your EPA.
Sorry you think not dealing with the hassle of mail order is worth $100's/mo you could be saving on Vascepa. Sorry your short (along with bobo's) has lost 30% in just 5 weeks, not!
It is possible that the FDA was only looking for leverage during the ADCOM meeting last October. They may not have wanted to give an unconditional approval for ANCHOR without some guarantee that Amarin would complete the REDUCE-IT trial. Everybody has assumed that FDA was going to give a complete denial on the PDUFA date. Maybe the plan all along was to take unconditional approval off the table (by invalidating the Special Protocol Agreement) but still grant Amarin some kind of restricted use for ANCHOR. I do believe FDA does wants a completed REDUCE-IT trial in its current form without any modifications. They also know that Amarin needs additional revenue to do that. It is not like Amarin is asking for approval of a drug that does not work or has safety concerns. Vascepa met all of its Phase 3 endpoints and the safety profile is a dream for drug manufacturers.
My Dr recommended that I get away from the over the counter EPA product I was taking because she can't assure me that the purity and quality is accurate and consistent. She has me on Vascepa now. It's a relief knowing that the dosage and purity delivers as prescribed. I have to say "WHAT A DIFFERENCE!" I had no idea how much better Vascepa is than over the counter until I tried it. You can feel the the difference.
Anyway, thought I'd share my experience.
good luck to all