Amarin (NASDAQ:AMRN) announced Monday it has submitted a new drug application (NDA) to the US FDA for its AMR101 drug, intended to treat patients with very high triglycerides, or levels of a certain type of fat in the blood.
The NDA seeks approval for the marketing and sale of AMR101, which lowers the level of triglycerides in the bloodstream. The application is based on data from Amarin's two phase 3 trial of the drug, which tested for safety and efficacy.
Triglycerides are a type of fat found in the blood used to store excess and unused calories, and too much of this fat can contribute to the hardening and narrowing of your arteries, which can lead to diabetes, heart disease, and stroke. The levels of these fats in the bloodstream are classified into four categories: normal, borderline high, high, and very high.
In the U.S. alone, it is estimated that 75 million people have at least 'borderline high' levels of triglycerides, including 4 million people with 'very high' levels.
During Amarin's two phase 3 studies, AMR101 achieved all primary endpoints, including tolerability in comparison to a placebo.
"Data from our two pivotal Phase 3 studies show that, unlike other triglyceride-lowering therapies, AMR101 does not increase LDL-cholesterol [a bad form of cholesterol] and, in certain cases, significantly decreases it," said CEO Joseph S. Zakrzewski.
"The submission of this NDA moves AMR101 one step closer to commercial launch. If AMR101 is approved, we believe it can play a significant role in cardiovascular health management."