Amarin (AMRN) Gets FDA Panel Nod For Vascepa Label Expansion
Zacks Investment Research | Nov 14, 2019 09:10PM ET
Amarin Corporation plc (NASDAQ:AMRN) announced that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to approve the label expansion for Vascepa (icosapent ethyl) capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol).
Notably, in May, the FDA granted a Priority Review to the supplemental new drug application (sNDA) for Vascepa. The sNDA is seeking approval for the label expansion of Vascepa to include data from the REDUCE-IT cardiovascular outcomes study.
If approved, Vascepa will be the first drug for this indication in the United States. The regulatory body has set an action date of Dec 28, 2019. However, the FDA is not bound by the recommendations of an advisory committee.
We remind investors that, Vascepa is already approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Shares of Amarin have soared 57.9% so far this year compared with the Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.