Landmark Cardiovascular Outcomes Study On-Track for Completion in 2018
BEDMINSTER, NJ, USA and DUBLIN, Ireland I August 14, 2017 I Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the scheduled pre-specified interim efficacy and safety analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. Because REDUCE-IT is the first prospective clinical trial of any therapy in the large patient population studied, the bars for stopping this trial early for overwhelming efficacy were intentionally set high with the understanding that a more robust result, based on a larger number of cardiovascular events, could be obtained by the study continuing to completion. Results from the completed study are expected in Q2 or Q3 2018. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces major adverse cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, this interim efficacy analysis was performed after adjudication of approximately 80% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a final efficacy analysis will be triggered by the onset of approximately 100% of the target aggregate number of primary cardiovascular events. Amarin anticipates that the onset of approximately 100% of events will likely occur in early 2018. Amarin is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is stopped and the database is locked at the final analysis.
The DMC’s recommendation to continue as planned also reflects its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in December 2011, and more than 30,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study.
The review and recommendation of the DMC at this interim look were made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC’s closed session deliberation.
“We are pleased that we are nearing completion of the REDUCE-IT study and thank the independent DMC members for their diligence in overseeing this important study,” said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. “This interim look provided important operational checks in preparation for study completion. We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of the existing and continually increasing body of data from clinical, epidemiologic, genetic, and real-world evidence studies, and we are preparing for the study conclusion.”
Residual cardiovascular risk in statin-treated patients
Cardiovascular disease remains the leading cause of death in the United States, with the estimated costs of treating heart attacks, strokes and other cardiovascular disease manifestations exceeding $550 billion annually.1 In the United States, about 40 million patients are treated with statins for the primary and secondary prevention of atherosclerotic cardiovascular events, including heart attacks and stroke.2 Despite the demonstrated clinical benefits of lowering bad cholesterol (LDL-C) with statins, 60% to 75% residual cardiovascular risk remains for statin-treated patients.3 Vascepa is being studied in REDUCE-IT as an add-on to statin therapy in patients with persistent elevated triglycerides and other risk factors to further reduce cardiovascular risk, not as a replacement for statin therapy.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
References
1 AHA Heart and Stroke Statistics https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf
2 http://www.acsh.org/news/2015/12/04/cdc-study-reveals-that-too-few-americans-are-on-statins
3 Libby P. J Am Coll Cardiol. 2005:46(7):1225-1228.
SOURCE: Amarin
Post Views: 39
Landmark Cardiovascular Outcomes Study On-Track for Completion in 2018
BEDMINSTER, NJ, USA and DUBLIN, Ireland I August 14, 2017 I Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the scheduled pre-specified interim efficacy and safety analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. Because REDUCE-IT is the first prospective clinical trial of any therapy in the large patient population studied, the bars for stopping this trial early for overwhelming efficacy were intentionally set high with the understanding that a more robust result, based on a larger number of cardiovascular events, could be obtained by the study continuing to completion. Results from the completed study are expected in Q2 or Q3 2018. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces major adverse cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, this interim efficacy analysis was performed after adjudication of approximately 80% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a final efficacy analysis will be triggered by the onset of approximately 100% of the target aggregate number of primary cardiovascular events. Amarin anticipates that the onset of approximately 100% of events will likely occur in early 2018. Amarin is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is stopped and the database is locked at the final analysis.
The DMC’s recommendation to continue as planned also reflects its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in December 2011, and more than 30,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study.
The review and recommendation of the DMC at this interim look were made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC’s closed session deliberation.
“We are pleased that we are nearing completion of the REDUCE-IT study and thank the independent DMC members for their diligence in overseeing this important study,” said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. “This interim look provided important operational checks in preparation for study completion. We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of the existing and continually increasing body of data from clinical, epidemiologic, genetic, and real-world evidence studies, and we are preparing for the study conclusion.”
Residual cardiovascular risk in statin-treated patients
Cardiovascular disease remains the leading cause of death in the United States, with the estimated costs of treating heart attacks, strokes and other cardiovascular disease manifestations exceeding $550 billion annually.1 In the United States, about 40 million patients are treated with statins for the primary and secondary prevention of atherosclerotic cardiovascular events, including heart attacks and stroke.2 Despite the demonstrated clinical benefits of lowering bad cholesterol (LDL-C) with statins, 60% to 75% residual cardiovascular risk remains for statin-treated patients.3 Vascepa is being studied in REDUCE-IT as an add-on to statin therapy in patients with persistent elevated triglycerides and other risk factors to further reduce cardiovascular risk, not as a replacement for statin therapy.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
References
1 AHA Heart and Stroke Statistics https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf
2 http://www.acsh.org/news/2015/12/04/cdc-study-reveals-that-too-few-americans-are-on-statins
3 Libby P. J Am Coll Cardiol. 2005:46(7):1225-1228.
SOURCE: Amarin
Post Views: 39
