Amarin Successfully Completes All Remaining Clinical Studies for NDA
Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, recently announced the successful completion of all remaining studies required for the company’s planned NDA for AMR101 for the treatment of patients with very high triglycerides (greater than or equal to 500 mg/dl). Completion of these studies is a key step in the company’s plans to submit an NDA for AMR101 by the end of September.
The company previously announced that it achieved all primary endpoints in its two pivotal Phase III clinical trials, both of which have SPA agreements with the FDA (MARINE and ANCHOR), and completed all preclinical studies. The company has now successfully completed all clinical pharmacology studies needed to characterize AMR101.
Furthermore, the company believes that it has met all of the requirements for the submission of a complete package of studies for the NDA for the treatment of patients with very high triglyceride levels. All findings from these clinical pharmacology studies were consistent with the company’s expectations with no AMR101-related inhibition in metabolism of the drugs studied. These results reinforce the company’s perspective from its Phase III clinical trials that the overall safety profile of AMR101 is comparable to placebo.
“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 (greater than or equal to 500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (> 200 and < 500 mg/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 III clinical trials.
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The company’s lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase III clinical trials.
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