THERAPEUTIC FOCUS

THERAPEUTIC FOCUS

CARDIOVASCULAR

Cardiovascular disease encompasses many different diseases with patients often suffering from multiple conditions. It is estimated that total U.S. pharmaceutical sales in the cardiovascular segment in 2006 were approximately $43.7 billion.

DYSLIPIDEMIA
Over 50% of U.S. CHD patients have dyslipidemia, including elevated blood cholesterol levels, with the overall U.S. dyslipidemia population believed to be in excess of 100 million. Dyslipidemia may be manifested by:

  • high levels of "bad" low-density lipoprotein cholesterol (LDL-C),
  • high levels of triglycerides and
  • low levels of "good" high-density lipoprotein cholesterol in the blood (HDL-C).

Hypertriglyceridemia, a component of dyslipidemia where patients have high blood levels of triglycerides, is associated with increased levels of heart disease. It is estimated that over 40 million people in the U.S. have hypertriglyceridemia (TG >200mg/dL).

Mixed dyslipidemia, a component of dyslipidemia, refers to a condition in which patients have a combination of two or more lipid abnormalities including elevated triglycerides, low HDL-C, and elevated LDL-C.

AMR101 has completed Phase 3 clinical development for the treatment of hypertriglyceridemia in patients with very high triglycerides (≥500mg/dl) and for patients with high triglycerides (≥200 and <500mg/dl) who also have mixed dyslipidemia. Amarin submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in September 2011 requesting approval to market and sell AMR101 for the indication being studied in the MARINE trial in the United States. The submission is based on the entire data set from the Company's AMR101 development program, including safety and efficacy data from the Phase 3 MARINE and ANCHOR studies. In order to obtain a separate indication for AMR101 based on the ANCHOR trial results, the FDA requires that we have a clinical outcomes study substantially underway at the time of the NDA filing.

In accordance with the three Special Protocol Assessment Agreements (SPA) that the Company has with the FDA, one each for the MARINE trial, the ANCHOR trial and the REDUCE-IT cardiovascular outcomes study, clinical results of the of the cardiovascular outcomes study are not required to obtain approval for the indication studied in the ANCHOR trial and no outcomes study is required in connection with the MARINE trial.

 

This page was last updated on October 13, 2011.