Amarin issues statement related to recent action by FDA for fenofibrate drugs

Amarin (AMRN) Corporation issued the following statement in response to the recent action taken by the U.S. Food and Drug Administration, FDA, to update the labeling for fenofibrate drugs in association with cardiovascular care: “We applaud the FDA’s decision to revise the labeling of fenofibrates. The updated labeling now includes a clear statement on the lack of cardiovascular benefit, relevant safety data, and a refined indication… We are hopeful this revision prompts a long-overdue shift in clinical practice, away from treatments that lack cardiovascular benefit, and toward assuring patients receive therapies that are clinically proven and FDA-approved to reduce cardiovascular events, including heart attack and stroke. Cardiovascular disease remains the leading cause of death globally, responsible for over 900,000iv deaths annually in the U.S. and nearly 20 million deaths worldwide. “