Amarin - The Science Of Lipid Therapy (Seite 54)
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👍Icosapent Ethyl Included in the Chinese Society of Cardiology Updated Guidelines for Primary Prevention of Cardiovascular Diseases👍
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include “icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population.”1
“Inclusion of icosapent ethyl in the CSC treatment guidelines further validates the increasing independent support and acceptance of this unique drug to reduce cardiovascular risk,” stated Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “Importantly, these updated guidelines also support that the preventive effect of omega-3 fatty acids on ASCVD is not only related to the dose, but also to the type and formulation of omega-3 fatty acid and incorporates findings from the REDUCE-IT cardiovascular outcomes study of VASCEPA®.”
“With this new recommendation, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event,” added Dr. Granowitz. Similar to Europe, where the European Society of Cardiology and the European Atherosclerosis Society added icosapent ethyl to their medical treatment guidelines prior to completion of the ongoing regulatory submission and review processes for VASCEPA (icosapent ethyl), CSC inclusion of icosapent ethyl in its updated treatment guidelines has been made separate from and in advance of completion of the analogous regulatory processes for VASCEPA in China.
In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin’s partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. This pivotal study mirrored Amarin’s MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China.
The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The CSC does not provide endorsements of any brand name commercial product. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA.
Amarin acknowledges the rigor with which the Guidelines for Primary Prevention of Cardiovascular Diseases are crafted and approved by the CSC, which is comprised of leading medical professionals in China who specialize in the care of patients with cardiovascular disease.
The complete 2021 updates to the Guidelines for Primary Prevention of Cardiovascular Diseases from the CSC can be accessed online here
There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (≥500 mg/dL). In 2019, there were approximately 36.1 million statin-treated adult patients in China with elevated TG levels (≥150 mg/dL) and either established CVD or diabetes mellitus and two or more additional risk factors for CVD, the addressable patients of the U.S. FDA-approved indication for reducing CV events of VASCEPA in China.
https://finance.yahoo.com/news/icosapent-ethyl-included-chin…
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include “icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population.”1
“Inclusion of icosapent ethyl in the CSC treatment guidelines further validates the increasing independent support and acceptance of this unique drug to reduce cardiovascular risk,” stated Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “Importantly, these updated guidelines also support that the preventive effect of omega-3 fatty acids on ASCVD is not only related to the dose, but also to the type and formulation of omega-3 fatty acid and incorporates findings from the REDUCE-IT cardiovascular outcomes study of VASCEPA®.”
“With this new recommendation, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event,” added Dr. Granowitz. Similar to Europe, where the European Society of Cardiology and the European Atherosclerosis Society added icosapent ethyl to their medical treatment guidelines prior to completion of the ongoing regulatory submission and review processes for VASCEPA (icosapent ethyl), CSC inclusion of icosapent ethyl in its updated treatment guidelines has been made separate from and in advance of completion of the analogous regulatory processes for VASCEPA in China.
In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin’s partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. This pivotal study mirrored Amarin’s MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China.
The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The CSC does not provide endorsements of any brand name commercial product. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA.
Amarin acknowledges the rigor with which the Guidelines for Primary Prevention of Cardiovascular Diseases are crafted and approved by the CSC, which is comprised of leading medical professionals in China who specialize in the care of patients with cardiovascular disease.
The complete 2021 updates to the Guidelines for Primary Prevention of Cardiovascular Diseases from the CSC can be accessed online here
There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (≥500 mg/dL). In 2019, there were approximately 36.1 million statin-treated adult patients in China with elevated TG levels (≥150 mg/dL) and either established CVD or diabetes mellitus and two or more additional risk factors for CVD, the addressable patients of the U.S. FDA-approved indication for reducing CV events of VASCEPA in China.
https://finance.yahoo.com/news/icosapent-ethyl-included-chin…
Langsam scheinen die Investoren auf das vorhandene Potential aufmerksam zu werden ... 🙃
.....und außerdem Vascepa zum Behandeln auf der Agenda!
Antwort auf Beitrag Nr.: 66.489.995 von Magnetfeldfredy am 18.01.21 15:58:42
Einige Teilnehmer der "Chinarunde" scheinen das Wort " Sicherheitsabstand" bzw. "Maske tragen" in einem geschlossenen Raum nicht so wörtlich zu nehmen....🙈.
Ach ja,.....Sorry......China hat ja "coronamäßig" aktuell soweit alles im Griff..🤗
Zitat von Magnetfeldfredy: https://www.investorvillage.com/uploads/87669/images/Chinese…
Einige Teilnehmer der "Chinarunde" scheinen das Wort " Sicherheitsabstand" bzw. "Maske tragen" in einem geschlossenen Raum nicht so wörtlich zu nehmen....🙈.
Ach ja,.....Sorry......China hat ja "coronamäßig" aktuell soweit alles im Griff..🤗
Trading Spotlight
Antwort auf Beitrag Nr.: 66.485.282 von bernie55 am 18.01.21 11:15:55AMARIN ANNOUNCES COMMENCEMENT OF VASCEPA® CLINICAL DEVELOPMENT IN MAINLAND CHINA
Jan 17, 2018
BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics, today announced that a clinical trial of Vascepa® (icosapent ethyl) capsules in a patient population with severe hypertriglyceridemia (TG ≥500 mg/dL) has been commenced in Mainland China, or China, by Amarin's partner, Eddingpharm.
Under the parties' February 2015 agreement, Eddingpharm is responsible for Vascepa development, regulatory activities, commercialization and associated costs, including managing and funding this pivotal registration study.
Similar to the MARINE trial conducted by Amarin, the trial being conducted by Eddingpharm in China is a multi-center, placebo-controlled, randomized, double-blind, 12-week study that is enrolling patients with severe hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG. The study's primary endpoint is the percentage change in triglyceride levels from baseline compared to placebo after 12 weeks of treatment. Eddingpharm anticipates that the study will be completed within the next two years. This clinical trial puts Vascepa on track to be the first ever pure prescription grade EPA based drug product in China. The parties believe the commercial opportunity in China is largely based on the prevalence of hypertriglyceridemia, which is estimated to affect around 17.7%1 of the adult Chinese population, about 185 million people.2
In November 2010, Amarin reported top-line results for the MARINE trial which met its primary and other key efficacy endpoints. The MARINE trial demonstrated that Vascepa 4g/day significantly lowered triglycerides by 33% compared to placebo without increasing LDL-C (non-significant decrease of 2% vs. placebo). In addition, Vascepa demonstrated a statistically significant decrease compared to placebo in multiple other important lipid biomarkers in MARINE including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), total cholesterol (TC) and the inflammatory marker high-sensitivity C-reactive protein (hsCRP).
https://investor.amarincorp.com/news-releases/news-release-d…
Jan 17, 2018
BEDMINSTER, N.J. and DUBLIN, Ireland, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics, today announced that a clinical trial of Vascepa® (icosapent ethyl) capsules in a patient population with severe hypertriglyceridemia (TG ≥500 mg/dL) has been commenced in Mainland China, or China, by Amarin's partner, Eddingpharm.
Under the parties' February 2015 agreement, Eddingpharm is responsible for Vascepa development, regulatory activities, commercialization and associated costs, including managing and funding this pivotal registration study.
Similar to the MARINE trial conducted by Amarin, the trial being conducted by Eddingpharm in China is a multi-center, placebo-controlled, randomized, double-blind, 12-week study that is enrolling patients with severe hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG. The study's primary endpoint is the percentage change in triglyceride levels from baseline compared to placebo after 12 weeks of treatment. Eddingpharm anticipates that the study will be completed within the next two years. This clinical trial puts Vascepa on track to be the first ever pure prescription grade EPA based drug product in China. The parties believe the commercial opportunity in China is largely based on the prevalence of hypertriglyceridemia, which is estimated to affect around 17.7%1 of the adult Chinese population, about 185 million people.2
In November 2010, Amarin reported top-line results for the MARINE trial which met its primary and other key efficacy endpoints. The MARINE trial demonstrated that Vascepa 4g/day significantly lowered triglycerides by 33% compared to placebo without increasing LDL-C (non-significant decrease of 2% vs. placebo). In addition, Vascepa demonstrated a statistically significant decrease compared to placebo in multiple other important lipid biomarkers in MARINE including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), total cholesterol (TC) and the inflammatory marker high-sensitivity C-reactive protein (hsCRP).
https://investor.amarincorp.com/news-releases/news-release-d…
👍 American cardiovascular drug Vascepa will enter Boao Lecheng👍
On the morning of January 17, the Vascepa clinical research kick-off meeting in Boao Lecheng Pioneer District was held at Boao Yiling Life Care Center. Liu Zhefeng, Deputy Director of Boao Lecheng International Medical Tourism Pilot Zone Administration; ...
This conference conducted in-depth discussions and exchanges on the research and practical application of Vascepa's real-world data, and jointly discussed the feasible path of Vascepa's clinical data collection and clinical research plan, and developed innovative ideas, unified and efficient actions, and worked together to accelerate the promotion of Vascepa in The domestic approval for listing also provides valuable experience for the regulatory model of innovative drugs and medical devices, allowing more domestic patients with cardiovascular and cerebrovascular diseases to use new, good, and assured drugs
At the meeting, Liu Zhefeng, deputy director of the Boao Lecheng International Medical Tourism Pilot Zone Administration, delivered a speech. He said that as the only "medical special zone" in the country and one of the key parks for the construction of Hainan Free Trade Port, Lecheng Pioneer Zone has always been a test field for bold experiments, bold breakthroughs, and independent reforms.
The implementation of the pilot work for the application of clinical real-world data in Boao Lecheng, Hainan, is to make full use of the advantages of the policy system and mechanism of the Lecheng Pilot Area, and is an extension of the policy of urgently needed imported licensed medicines and devices in Lecheng clinical.
Deng Jianwei, Vice President of Eton Pharmaceuticals, said: "We are pleased to see that Vascepa, a new drug that reduces cardiovascular risk, has been approved for first use. The U.S. Food and Drug Administration (FDA) approved Vascepa as a supplement to the maximum tolerance of statins In order to reduce cardiovascular risk, the introduction of this new drug is another successful practice of the licensing policy of the pilot zone. Looking forward to the future, Eton Pharmaceuticals will continue to introduce innovative drugs into the park at a faster rate, benefiting more Domestic patients."
"Before today's seminar, I have studied for many days and done a lot of homework." Yue Hongwen, director of Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment Center, said with excitement, "At present, Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment The center has established a special medical team to provide guarantee for the smooth implementation of the new drug introduced, and carry out comprehensive collection of patient feedback on clinical use, data statistics, real-world data research, etc. for the optimization of clinical pathways for chronic cardiovascular diseases. I also I very much hope that this new natural medicine, based on statins, can help more patients with chronic cardiovascular diseases, reverse coronary heart disease plaques (soft plaques), reduce the risk of cardiovascular malignant events, and unlock the heart of China A new era in the prevention and rehabilitation of chronic vascular diseases."
The introduction of Vascepa into Lecheng as the drug with the greatest tolerance to statins to reduce the cardiovascular risk of high-risk patients means that Chinese patients will simultaneously share this cutting-edge therapy with patients around the world. Professor Wu Yongjian from Fuwai Hospital of the Chinese Academy of Medical Sciences said that the advent of Vascepa further addresses the urgent need for excellent clinical efficacy in the field of cardiovascular therapy, and can effectively reduce the residual risk of a variety of major cardiovascular adverse events, in order to benefit more Chinese patients.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8066&pt=…
On the morning of January 17, the Vascepa clinical research kick-off meeting in Boao Lecheng Pioneer District was held at Boao Yiling Life Care Center. Liu Zhefeng, Deputy Director of Boao Lecheng International Medical Tourism Pilot Zone Administration; ...
This conference conducted in-depth discussions and exchanges on the research and practical application of Vascepa's real-world data, and jointly discussed the feasible path of Vascepa's clinical data collection and clinical research plan, and developed innovative ideas, unified and efficient actions, and worked together to accelerate the promotion of Vascepa in The domestic approval for listing also provides valuable experience for the regulatory model of innovative drugs and medical devices, allowing more domestic patients with cardiovascular and cerebrovascular diseases to use new, good, and assured drugs
At the meeting, Liu Zhefeng, deputy director of the Boao Lecheng International Medical Tourism Pilot Zone Administration, delivered a speech. He said that as the only "medical special zone" in the country and one of the key parks for the construction of Hainan Free Trade Port, Lecheng Pioneer Zone has always been a test field for bold experiments, bold breakthroughs, and independent reforms.
The implementation of the pilot work for the application of clinical real-world data in Boao Lecheng, Hainan, is to make full use of the advantages of the policy system and mechanism of the Lecheng Pilot Area, and is an extension of the policy of urgently needed imported licensed medicines and devices in Lecheng clinical.
Deng Jianwei, Vice President of Eton Pharmaceuticals, said: "We are pleased to see that Vascepa, a new drug that reduces cardiovascular risk, has been approved for first use. The U.S. Food and Drug Administration (FDA) approved Vascepa as a supplement to the maximum tolerance of statins In order to reduce cardiovascular risk, the introduction of this new drug is another successful practice of the licensing policy of the pilot zone. Looking forward to the future, Eton Pharmaceuticals will continue to introduce innovative drugs into the park at a faster rate, benefiting more Domestic patients."
"Before today's seminar, I have studied for many days and done a lot of homework." Yue Hongwen, director of Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment Center, said with excitement, "At present, Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment The center has established a special medical team to provide guarantee for the smooth implementation of the new drug introduced, and carry out comprehensive collection of patient feedback on clinical use, data statistics, real-world data research, etc. for the optimization of clinical pathways for chronic cardiovascular diseases. I also I very much hope that this new natural medicine, based on statins, can help more patients with chronic cardiovascular diseases, reverse coronary heart disease plaques (soft plaques), reduce the risk of cardiovascular malignant events, and unlock the heart of China A new era in the prevention and rehabilitation of chronic vascular diseases."
The introduction of Vascepa into Lecheng as the drug with the greatest tolerance to statins to reduce the cardiovascular risk of high-risk patients means that Chinese patients will simultaneously share this cutting-edge therapy with patients around the world. Professor Wu Yongjian from Fuwai Hospital of the Chinese Academy of Medical Sciences said that the advent of Vascepa further addresses the urgent need for excellent clinical efficacy in the field of cardiovascular therapy, and can effectively reduce the residual risk of a variety of major cardiovascular adverse events, in order to benefit more Chinese patients.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8066&pt=…
Schaut doch gut aus!
Antwort auf Beitrag Nr.: 66.343.874 von Magnetfeldfredy am 08.01.21 10:44:24Scriptzahlen von tucaman:
Note that this we are coming out of a short week.
Vascepa
TRx: 85'920 (+2.81%)
NRx: 38'860 (+14.60%)
Generic Vascepa
TRx: 5'437 (+41.65%)
NRx: 2'944 (+60.00%)
Generic Lovaza
TRx: 63'667 (+3.38%)
NRx: 31'917 (+10.69%)
https://investorshub.advfn.com/boards/read_msg.aspx?message_…
Note that this we are coming out of a short week.
Vascepa
TRx: 85'920 (+2.81%)
NRx: 38'860 (+14.60%)
Generic Vascepa
TRx: 5'437 (+41.65%)
NRx: 2'944 (+60.00%)
Generic Lovaza
TRx: 63'667 (+3.38%)
NRx: 31'917 (+10.69%)
https://investorshub.advfn.com/boards/read_msg.aspx?message_…
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Amarin - The Science Of Lipid Therapy
