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Ethyl eicosapentaenoic acid (E-EPA, icosapent ethyl), sold under the brand name Vascepa among others, is a medication used to treat dyslipidemia [4] and hypertriglyceridemia. [3] It is used in combination with changes in diet in adults with hypertriglyceridemia ≥ 150 mg/dL. Further, it is often required to be used with a statin (maximally ...
Amarin (AMRN) gets favorable FDA Advisory Committee vote to expand the label of Vascepa capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides.
Omega-3 acid ethyl esters are used in addition to changes in diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. [10] In the European Union and other major markets outside the US, omega-3 acid ethyl esters are indicated for hypertriglyceridemia by itself, or in combination with a statin for people with mixed dyslipidemia.
The maker of fish oil drug Vascepa, a treatment for severe hypertriglyceridemia (triglyceride levels equal to or higher. It's been a brutal year for Amarin , which has lost more than 76% of its ...
Vascepa (ethyl eicosapentaenoic acid; icosapent ethyl) was approved on 26 July 2012. [78] [79] [80] On 13 December 2019, the FDA also approved it as the first drug specifically "to reduce cardiovascular risk among patients with elevated triglyceride levels." Vascepa is not approved as a monotherapy for lowering TGs: it must be taken with a ...
1 – Excludes restructuring expense of $10.0 million in the 3 months ended June 30, 2023. Total net revenue for the three months ended June 30, 2024 was $67.5 million, compared to $80.2 million in the corresponding period of 2023, a decrease of 16%.
Amarin faces the firing squad tomorrow when the Food and Drug Administration's advisory committee reviews its lipid-lowering drug Vascepa. The drug is already approved for patients with extremely ...
Amarin's decision from the Food and Drug Administration came a few days later than expected, but the result was as expected: The FDA turned down Amarin's appeal of the agency's decision to rescind ...