With Pfizer’s Lipitor® Available As A Cheap Generic, Does This FDA Resubmission Make Any Sense?

An observant commenter quite correctly reminded me that I hadn’t weighed in on this. And, as you might imagine, I’ve long-held opinions on it (that’s the backgrounder).

Whitehouse Station disclosed this week that the US FDA had accepted receipt of a resubmitted New Drug Application (that’s the long form — not an abbreviated one) for a cholesterol management combination pill. The combination is a generic version of Pfizer’s branded Lipitor® (atorvastatin), with legacy Schering-Plough’s Zetia® (ezetimibe) — all in one solid pill. [FDA had rejected such a proposal in March of 2012.]

The central problem with the thesis upon which this particular combo-pill is based is that. . . there is very scant evidence for it — and at least three failed (or null-result) similar study outcomes, as to actual cardio-vascular-event risk benefits, here. Specifically, the question is whether statins (of which generic atorvastatin is one) combined with Zetia (soon also to be available as a cheap generic form of ezetimibe) actually improve outcomes, or just lower the numbers, in blood levels, without any overall CV risk reduction effect.

So — with the Affordable Care Act of 2010 clearly applying new pressures on providers to use the vastly cheaper generic equivalents — who might prescribe this one-off pill?
In addition, given that the massive (32,000 patients!) IMPROVE-IT study isn’t likely to answer the question on any CV risk benefit from simvastain plus ezetimibe until mid 2014. . . what is the rationale for allocating capital in 2013 to a resumbitted NDA?

Perhaps — just perhaps — I might answer my own question by suggesting that New Merck had already spent the vast bulk of the money, in 2011 and early 2012, when it made the first NDA submission to FDA. And so, all it is doing is finishing up on the spend — on the relatively-small chance that the thesis for CV risk reduction via statin-ezetimibe combinations turns out to be supported by actual science, at some future date.

I hope that is the case — that most of this was spent money, already — sunk cost. And that only a smallish portion (some $5 to $10 million) will be needed to get definitive word back from FDA.

I hope.

In any event, here is the presser:

. . . .Merck. . . announced. . . that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. The updated NDA was deemed complete for review after Merck submitted additional data in response to the FDA’s Complete Response Letter issued last year. Merck expects the FDA’s review to be completed in the first half of 2013. . . .

Well — here’s to hoping, I guess.


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