News Focus
News Focus
icon url

DewDiligence

12/13/19 4:31 PM

#227656 RE: Whalatane #227645

AMRN’s Vascepa gets expanded label:

https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups

The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels…of 150 milligrams per deciliter or higher.

Patients must also have either established cardiovascular disease or ( diabetes and two or more additional risk factors for cardiovascular disease ).

Bold-faced emphasis—and red parentheses in the second paragraph (to facilitate parsing)—were added by me.

The word, "adjunctive" in this context presumably means combination therapy with a statin.