Amarin Corp Plc (AMRN)

[HDGabor]

BB,

Vascepa will have a clear label for Trigs>150 in high risk patients.

What is it means?

Epanova / Lovaza / Vascepa had, has and will have (more or less) the same Limitations of Use condition till R-IT result:

'Limitations of Use:
• The effect of .... on the risk for pancreatitis has not been determined.
• The effect of ... on cardiovascular mortality and morbidity has not been determined.'

and had, has and will have (more or less) the same indication till ANCHOR approval:

'indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>= 500 mg/dL) hypertriglyceridemia.'

after ANCHOR approval VASCEPA will be the only one with indication for high triglycerides (>=200 mg/dL and <500 mg/dL)

after succesfull R-IT and approval the second L of U (cardio ...) will be deleted, but the first (for pancreatitis) not, plus the indication will contains the borderline high triglycerides (>=150 mg/dL and <200 mg/dL) or indication will remains the same since design of R-IT was changed to TG (>=200 mg/dL).