This comment was posted by JSchiable on AF's most recent article on The Street.
Is there merit to any of this?
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Next step? My two cents?
$AMRN needs to file for Fast Track for Vascepa in Mix Dyslipidemia right now. I know...for an already approved drug? On an indication the Agency already declined? Crazy, right?
But consider that when one reads the regs and between the lines, it is clear the $AMRN SPA gave the box checking FDA bureaucrats hives given it is seen to be little more than an Accelerated Approval end run (an approval based on a surrogate endpoint along with a commitment to provide the confirmatory event evidence.) But (as of now) Vascepa does not QUALIFY for Accelerated Approval, which was cryptically confirmed at the end of the AdCom by FDA staff...so long as Vascepa does not have an SPA and has not applied for FT status in this indication. So the FDA can hide behind a fig leaf to say they are trying to be consistent with law and policy, and thus must deny even CONSIDERATION for access to any defacto AA pathway. (Consistent? I know...bear with me...)
But if $AMRN does file for FT? Well, then it puts the SCIENCE back in the driver seat, and forces the FDA's hand.
The FDA would then be required to take a stand on the following:
A) Is Mix Dyslipidemia a "serious condition"? The science backs that there is (in the FDA's own words) a high "likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one". While this is a judgment call, I suspect the FDA would never want to be pinned down to say otherwise. If A, then we move to the 2nd part of FT process.
B) Is it also an "unmet medical need"? Actually, this one is easy. For by the FDA's own word's. if there is "no available therapy there is clearly an unmet medical need." Well, there is NO approved medication for this indication, and so the FDA would be painted into a corner. Either it would need to grant FT or to admit that there are available therapies for the condition... there by endorsing off label use of prior approved meds in this setting ... including Vascepa, and given Amarin's 1st amendment arguments a huge boost.
The beauty of FT is that no one is expecting it and it is so simple to do. It requires NO new Vasepa data... or even ANY Vasepa data. And with by some miracle they get the FT? Immediately refile the sNDA with supportive data on mixed dyslipidemia being a surrogate endpoint to CV events.
But ...but...I hear you say.... an FT for an already approved drug? Yep. The FDA has already established a precedence for granting FT to other sNDA indications
(ex. Lymphoseek by Nacidea). And note, Amarin has already held an FDA granted FT for a highly purified EPA (for Huntington's back when it was formulated as Miraxion).
As I see it, they have little to lose trying the FT tactic.
