Stifel analyst Derek Archila sees a "high probability" that the U.S. Food and Drug Administration will expand the label for Amarin Corporation's (AMRN) Vascepa following its November 14 panel meeting. Meanwhile, Goldman Sachs analyst Paul Choi said he believes FDA briefing documents for the meeting are "at odds" with the broad label being sought by the company, though he still sees a high likelihood of a positive vote on the label expansion.
VASCEPA SNDA MEETING: The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet Thursday, November 14 to discuss Amarin's suplemental New Drug Application, or sNDA, for Vascepa for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease. The Prescription Drug User Fee Act target date for action on Amarin's sNDA is December 28.
On Wednesday, the FDA posted briefing documents ahead of the meeting to discuss the benefits and risks of Vascepa for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated triglyceride levels and other risk factors for cardiovascular disease. "The major topics for the panel to address include the robustness of this single trial to support a new indication for CV risk reduction, identification of the appropriate indicated population, whether it is appropriate to include in the indication in labeling all of the components of the primary endpoint," the documents stated. The documents added that "Although there is less plausibility for an interaction between mineral oil and other background cardiovascular medications with known CV benefits, we considered whether trial data indicated any effects on these drugs that might further impact the observed effect of AMR101 on outcomes. We concluded that these analyses showed no evidence of such a signal."
'HIGH PROBABILITY' OF LABEL EXPANSION: Stifel analyst Derek Archila believes the questions raised in Tuesday's briefing documents "look pretty broad," and that investor fears of potential issues with Vascepa's study design or safety should be alleviated given the tone of the documents, he said in a research note to investors. The analyst thinks Amarin shares trade up today ahead of the panel vote and believes there is a "high probability" the panel is positive and the FDA subsequently approves Vascepa's supplemental new drug application to include cardiovascular risk reduction.
DOCS 'LEAN TOWARD NARROW LABEL: Goldman Sachs analyst Paul Choi told investors in a research note of his own that while shares of Amarin are trading significantly higher, he expects the stock to revert lower as he believes the FDA documents are "at odds" with the broad label being sought by the company. Choi stated that the briefing documents indicate that FDA staff said "the trial inclusion criteria and data do not appear to support such a broad population" as the one being sought by Amarin. Choi said he still sees a high likelihood of a positive vote on the label expansion, saying that the agency "seems aligned with Amarin" on the benefit of patients with established CVD with elevated triglycerides despite optimized stating therapy, but feels the expansion will be for a smaller subset of patients compared to what Amarin is seeking.
PRICE ACTION: In morning trading, shares of Amarin are up over 18% to $20.01.