Amarin's New Drug Application Set To Be Submitted This Quarter |
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By Staff and Wire Reports | |
Monday, 01 August 2011 07:19 | |
![]() "The completion of these final studies clears the way for our NDA submission by the end of next month," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The Amarin team is now focused on completing the final work for the AMR101 NDA package, and we are looking forward to moving into the regulatory review process." AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>=500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 intentionally excludes DHA, which is believed to result in increases in LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase 3 clinical trials. Amarin also has next-generation lipid candidates under evaluation for preclinical development. ![]() "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |