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news.Amarin's New Drug Application (NDA) for AMR101(icosapent ethyl), used to treat patients with very high triglycerides, has received FDA approval.
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AMR101 is a prescription-grade omega-3 fatty acid, consisting at least 96% ultra pure EPA (icosapent ethyl).
The NDA for AMR101 is backed by data from the two Phase 3 AMR101 clinical trials- MARINE and ANCHOR trial.
According to the company, AMR101 met all the primary endpoints in both the trials and was well tolerated with a safety profile comparable to placebo.
Amarin chairman and CEO Joseph Zakrzewski said the NDA approval from FDA would provide a boost for the development of next generation Omega-3 based triglyceride lowering therapy.