This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
With the FDA advisory panel voting last night 9-2 to recommend against expanding Vascepa's approval to include the treatment of patients with mixed dyslipidemia, what will the FDA ultimately decide?
FDA advisory panels are just that -- advisory. Votes are not binding. But in this case, it's almost impossible to conjure a scenario under which FDA approves Vascepa for mixed dyslipidemia patients -- the so-called "ANCHOR" indication
we discussed on Tuesday.
FDA is expected to announce the Vascepa decision on Dec. 20.
I believed FDA went into Wednesday's advisory panel not wanting to approve Vascepa without cardiovascular outcomes data. The agency convened the advisory panel in order to get agreement from outside experts, which is what happened.
If FDA follows the negative recommendation of Wednesday's advisory panel, will Amarin be forced to stop selling Vascepa?
No! Absolutely not. Vascepa is approved to treat patients with very high levels of triglycerides in their blood. Nothing about this approved indication changes as a result of Wednesday's negative vote, or when FDA ultimately follows through on Dec. 20.
Of course, without an expanded approval for mixed dyslipidemia patients, Vascepa's sales potential is much lower. That's not good for Amarin.
What does Amarin do now?
The panel experts made it clear they want to see data demonstrating Vascepa can provide cardiovascular benefit -- fewer heart attacks, strokes, heart-related hospitalizations and deaths -- in mixed dyslipidemia patients. FDA concurs.
Amarin is conducting the "Reduce-IT" study right now, specifically designed to answer this question.
When will Amarin complete the "Reduce-IT" study?
Amarin has about 6,000 of 8,000 patients enrolled in the study, with enrollment expected to be completed in early 2015. An interim analysis is planned that could be conducted in late 2015. If the interim analysis comes back inconclusive, the final results will be ready in late 2017.
2017? That's a long wait!
It is, yet Amarin has no choice but to bite the bullet and complete the Reduce-It study. Getting a definitive answer to the question of whether or not prescription fish oil provides real cardiovascular benefit to patients is incredibly important. Amarin is in the best position to provide that answer. If Reduce-It is positive, Amarin will reap the rewards because Vascepa will be a much more valuable drug.
On a conference call Wednesday night, Amarin's CEO left open the possibility that the Reduce-IT study would be shut down.
I know. I heard the call. Shuttering Reduce-It would be a huge strategic mistake for Amarin and a terrible loss for the medical community, not to mention an ethical travesty because it would abandon all the patients already enrolled.