Amarin - The Science Of Lipid Therapy (Seite 108)
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Antwort auf Beitrag Nr.: 62.157.326 von Magnetfeldfredy am 13.12.19 23:21:09
Zitat von Magnetfeldfredy: Super geil, freut mich für alle Patienten und Aktionäre, Buyout wird 2020 kommen, US Dollar 50!
Super geil, freut mich für alle Patienten und Aktionäre, Buyout wird 2020 kommen, US Dollar 50!
Antwort auf Beitrag Nr.: 62.157.203 von bernie55 am 13.12.19 22:52:03Das heisst es ist nicht das gaaanz große Label, wurde also entsprechend eingeschränkt, es ist aber auch nicht die Minimallösung = mittleres Endergebnis
Für mich eine realistische und nachvollziehbare Zulassung. Vascepa als Wunderheilmittel für alles anzupreisen was in manchen Foren so geschrieben wurde war ja immer schon deutlich übertrieben.
Denke wir können zufrieden sein, bin mal gespannt wie das im Aktienmarkt ankommt und wohin die Reise die nächsten Tage führt.
Was meint ihr ist eine Partnerschaft/BO damit eher realistischer geworden da nun Amarin Potential sehr gut aber ist aber auch nicht zuu teuer werden wird so dass ein solcher Schritt eher wahrscheinlicher wird als unwahrscheinlicher ?
Für mich eine realistische und nachvollziehbare Zulassung. Vascepa als Wunderheilmittel für alles anzupreisen was in manchen Foren so geschrieben wurde war ja immer schon deutlich übertrieben.
Denke wir können zufrieden sein, bin mal gespannt wie das im Aktienmarkt ankommt und wohin die Reise die nächsten Tage führt.
Was meint ihr ist eine Partnerschaft/BO damit eher realistischer geworden da nun Amarin Potential sehr gut aber ist aber auch nicht zuu teuer werden wird so dass ein solcher Schritt eher wahrscheinlicher wird als unwahrscheinlicher ?
AMARIN RECEIVES FDA APPROVAL OF VASCEPA® (ICOSAPENT ETHYL) TO REDUCE CARDIOVASCULAR RISK
Dec 13, 2019
VASCEPA becomes the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment
Millions of people in the United States qualify as treatment candidates for VASCEPA
Cardiovascular disease events, including heart attack, stroke and cardiovascular death, occur in the United States every 14 seconds and are economically, physically and emotionally costly
VASCEPA has been assessed by independent bodies as priced cost effectively as a cardiovascular risk reduction treatment
VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million
Amarin to host webcast on Monday, December 16 at 7:30 a.m., Eastern Time
https://investor.amarincorp.com/news-releases/news-release-d…
Dec 13, 2019
VASCEPA becomes the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment
Millions of people in the United States qualify as treatment candidates for VASCEPA
Cardiovascular disease events, including heart attack, stroke and cardiovascular death, occur in the United States every 14 seconds and are economically, physically and emotionally costly
VASCEPA has been assessed by independent bodies as priced cost effectively as a cardiovascular risk reduction treatment
VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million
Amarin to host webcast on Monday, December 16 at 7:30 a.m., Eastern Time
https://investor.amarincorp.com/news-releases/news-release-d…
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Antwort auf Beitrag Nr.: 62.157.113 von bernie55 am 13.12.19 22:39:40Somit stehen sowohl die Primär- als auch die Sekundärprävention auf dem Label, wobei sich die Primärprävention auf Diabetiker plus 2 zusätzliche Faktoren ( Alter und Triggern über 150 ) bezieht.
Sekundärprävention bezieht sich auf die Patienten, die bereits Statine einnehmen.
Sekundärprävention bezieht sich auf die Patienten, die bereits Statine einnehmen.
The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.
Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.
Patients are advised to continue physical activity and maintain a healthy diet.
Vascepa is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Statins are drugs used to treat elevated cholesterol levels and reduce the risk of cardiovascular events.
“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”
High levels of triglycerides can play a role in the hardening of arteries or thickening of the artery wall, which can increase the risk of a heart attack or stroke; however, the mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood.
Vascepa’s efficacy and safety were established in a study with 8,179 patients who were either 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease. Patients who received Vascepa were significantly less likely to experience a cardiovascular event, such as a stroke or heart attack. Vascepa’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. Vascepa is taken orally.
In clinical trials, Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter (irregular heart rhythms) requiring hospitalization. The incidence of atrial fibrillation was greater among patients with a history of atrial fibrillation or atrial flutter. Vascepa was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time.
Patients with allergies to fish or shellfish should be advised about the potential for allergic reactions. They should discontinue treatment and seek medical attention if any allergic reactions occur.
The most common side effects reported in the clinical trials for Vascepa were musculoskeletal pain, peripheral edema (swelling of legs and hands), atrial fibrillation and arthralgia (joint pain).
Vascepa was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review. The FDA grants priority review to applications for drugs that, if approved, would improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
The approval of Vascepa was granted to Amarin Pharma Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.
Patients are advised to continue physical activity and maintain a healthy diet.
Vascepa is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Statins are drugs used to treat elevated cholesterol levels and reduce the risk of cardiovascular events.
“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”
High levels of triglycerides can play a role in the hardening of arteries or thickening of the artery wall, which can increase the risk of a heart attack or stroke; however, the mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood.
Vascepa’s efficacy and safety were established in a study with 8,179 patients who were either 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease. Patients who received Vascepa were significantly less likely to experience a cardiovascular event, such as a stroke or heart attack. Vascepa’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. Vascepa is taken orally.
In clinical trials, Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter (irregular heart rhythms) requiring hospitalization. The incidence of atrial fibrillation was greater among patients with a history of atrial fibrillation or atrial flutter. Vascepa was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time.
Patients with allergies to fish or shellfish should be advised about the potential for allergic reactions. They should discontinue treatment and seek medical attention if any allergic reactions occur.
The most common side effects reported in the clinical trials for Vascepa were musculoskeletal pain, peripheral edema (swelling of legs and hands), atrial fibrillation and arthralgia (joint pain).
Vascepa was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review. The FDA grants priority review to applications for drugs that, if approved, would improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
The approval of Vascepa was granted to Amarin Pharma Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups
https://www.fda.gov/news-events/press-announcements/fda-appr…
https://www.fda.gov/news-events/press-announcements/fda-appr…
Antwort auf Beitrag Nr.: 62.156.621 von flyingbeef am 13.12.19 21:21:59
Morgen einfach weiteres Popcorn kaufen.
News können auch erst am Montag rauskommen - vielleicht mit Pressekonferenz ?
Zitat von flyingbeef: Uiuiui die lassen sich aber Zeit, mein Popcorn ist bald alle menno und was mach ich dann
Morgen einfach weiteres Popcorn kaufen.
News können auch erst am Montag rauskommen - vielleicht mit Pressekonferenz ?
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Amarin - The Science Of Lipid Therapy
