Wednesday, September 11, 2019 11:11:55 PM
So, I think most important is that it'd be a cardiovascular risk reduction indication today, or approved for, is an important but niche indication for treatment of patients with triglyceride levels greater than 500 mgs per deciliter, which is a population of patients at risk for pancreatitis in the is U.S. about two million to four million patients with that level of risk in the cardiovascular risk reduction, indication if we look at patients, for example with triglyceride levels of 135 mgs per deciliter or greater. And there's data out there suggesting that cardiovascular risk begins to increase as triglycerides unit levels lower than 100 mgs per deciliter.
But if we just look at the population of patients with triglycerides from 135 and above, that's about 90 million people in the United States. If we look at statin treated patients with elevated triglycerides 135 and above, that's about 15 million patients in the United States. So these are big numbers and with a cost effective therapy like Vascepa, we see this as being the first opportunity to treat these patients with a proven therapy.
Joel Beatty
Got it. And then as we’ve seen some – from some of the guidelines, it seems like the focus is on using Vascepa, in patients, maybe above a certain triglyceride cut off but also with higher risk patients. Any talk about these large numbers, I'd say like 90 million in the U.S. with triglycerides 135 and up, are there different ways to cut that, maybe focusing on higher risk patients that, give us a sense of what the market opportunity could be.
John Thero
Yes, I mean, a good point. I mean, if you think about, statins for example, when they were originally introduced, the initial focus was on, patients with LDL levels in north of 200 and then it came down to 180 and 150 and then 100, and then it really, now it's, the lower, lower the better.
I envision that with Vascepa, as we get the label approval and physicians begin to become more knowledgeable of it and use it, they will start with their highest risk patients. This will be statin treated patients, as statins are proven, they've been out in the marketplace for 25 years and, we're not trying to replace statin therapy. Rather we're trying to deal with the multi-factorial risk that exists beyond cholesterol management.
So they'll probably start with diabetic patients, they’ll probably start with patients with an established cardiovascular disease and then probably over time migrate to things like pre-diabetic patients or the patients with other cardiovascular risks. Again, all of these are large populations or subgroups of that number.
And all these really don't have any proven therapy really. They do not have any proven therapy. So Vascepa offers an opportunity to provide a great help to these millions or tens of millions patients.
Joel Beatty
Okay. It seems to me that Vascepa is in a relatively unique situation and that there's already a few prominent guidelines out there talking about it’s use, at the same time while the label hasn't even been granted yet, it's still under review by FDA. The question is how likely is it or how much weight could FDA be giving to these guidelines and then they consider the review.
John Thero
So, FDA has a advisory panel, that they tend to be scheduled for November 14, of this year. As a first ever drug for this large indication, it doesn't surprise us that the FDA is going to have an advisory committee meeting. And anytime you're going through an advisory committee meeting for a first kind of drug, you'd expect that, that review will be, fairly comprehensive. The extent to which the FDA would be looking at, opinions from key opinion leaders and medical societies and patient advocacy groups, relative to its decision making, really is up to the FDA.
I think it is remarkable that, these leading groups recognizes this large need for treating these at risk patients where there isn't any proven therapy today. And I'm certainly hopeful that FDA will take note of, those positions, and move rapidly, to position Vascepa to become available for broad care of these at-risk patients.
Recent AMRN News
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/26/2024 12:00:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/24/2024 09:31:21 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM