Amarin's ($AMRN) hopes of expanding the label for its omega-3 pill look even bleaker as the FDA has denied the company's appeal to reconsider its clinical data, sending shares down another 25% in premarket trading Tuesday. Perhaps unsurprisingly, the ever-optimistic Amarin has vowed to keep fighting for Vascepa, planning to make its case to a higher branch of the FDA.
The issue centers on Vascepa's special protocol assessment (SPA), under which Amarin and the FDA came to an accord that a significant drop in triglyceride levels in the drug's pivotal study would be enough to indicate an improvement in cardiac outcomes for certain patients. Back in October, the agency changed its mind on the issue, pointing to new data that question that hypothesis and rescinding the SPA. Amarin appealed that decision in an effort to salvage its Phase III work on Vascepa, but has now heard back from the Division of Metabolism and Endocrinology Products that the decision stands.
Amarin isn't calling it quits, planning instead to file an appeal with the FDA's director of the Office of Drug Evaluation II, which is the next level under the agency's dispute-resolution guidance. Meanwhile, the FDA has indefinitely postponed a final ruling on Vascepa, initially expecting to weigh in by Dec. 20 but now pushing that date back to allow for Amarin's spiraling appeal process.
The latest setback sent Amarin's shares down another 25% to about $1.70 before markets opened on Tuesday, and the company has fallen more than 75% since it first ran into FDA trouble in October.
Before the agency abandoned its support for Amarin's SPA, a panel of advisers voted 9-2 against recommending the drug be approved for an expanded patient population, suggesting the agency hold off until it gets a glimpse of the results of a clinical trial on coronary outcomes that won't wrap up until 2016. That decision sent Amarin's shares down more than 60%, leading the company to cut costs and payroll, and likely spelling the demise of CEO Joe Zakrzewski, who retired on Jan. 1.
As for Amarin's current appeal gambit, if the company gets rebuffed at the office director level, it can reach up to the deputy director of the Center for Drug Evaluation and Research (CDER), according to FDA guidance. And if that doesn't work out, the company can make a final case to CDER Director Janet Woodcock.
- read Amarin's statement
- check out the FDA's appeal guidance (PDF)