Shares of Amarin Corporation (AMRN) plunged more than 60% in Thursday morning trading after a regulatory agency recommended against the approval of its cholesterol drug.
On Wednesday, an advisory panel for the U.S. Food and Drug Administration (FDA) declined to approve Vascepa for use in patients who have a higher risk of heart disease and already take a statin medication to combat cholesterol. The panel voted 9-2 against clearing the drug, asserting that its benefits had not yet been adequately demonstrated, Reuters noted.
Though the FDA is not required to follow the panel’s guidance, it is unlikely to ignore its findings. A trial of Vascepa in 8,000 patients is currently in progress with results expected in 2016. The FDA has indicated that approval for the drug could be delayed until the results of that study are known.
On analyst said that Amarin would likely be forced to seek more funding to continue its research until the study was concluded.