Thursday, May 20, 2010

Why -- Exactly -- Is Zetia® + Lipitor® Combo Delayed, At FDA?

This all started at New Merck's R&D Day webcast last Tuesday, and continued at the Banc of America conference presentation made by Merck, a few days later, on Thursday.

Tonight, as Matt Herper, for Forbes, ably notes, if the FDA's increased disclosures initiative makes its way into the rule book intact, we will no longer be left to wonder what -- exactly -- is the holdup at FDA on putatively new drugs, like a Zetia® (ezetimibe) plus Lipitor® (atorvastatin) combo. Here's Matt's piece -- do go read it all:

. . . .Making the [FDA's] letters public will prevent companies from misleading investors about what went wrong, he wrote, but it will also prevent rumors that things are worst than they are. . . .

For instance, at Merck's recent analyst meeting some Wall Streeters wonder whether an FDA delay in approving a combination of Merck's Zetia and the soon-to-be-generic Lipitor reflects concerns on the FDA's part about Zetia. Merck says it comes down to manufacturing issues. In the future, there may not be any argument to have. . . .

Let us all hope so. [A private commenter points out that I have been too opaque, above. So -- for the record, I think such a pill isn't much of a meaningfully "new drug", at all -- and while Lipitor is a wonderful drug, there is little evidence to suggest that Zetia is doing anything to improve clinical outcomes. So, it would be reasonable to infer that FDA is taking a "wait and see" approach, until the results from IMPROVE-IT become known (that is Zocor® plus Zetia®, in the Merck-marketed combo pill called Vytorin®) -- as it is also a statin (simvastatin), plus ezetimibe. Could well be. And that could be 2014, or even beyond.]


Anonymous said...

True that Zocor and Lipitor are both statins... but I would not be surprised if the combination of L + Zetia is more effective that Z + Zetia... slight differences chemically can have big differences biologically; and this is further complicated by differences in the response of certain individuals to the combinations.

I am a betting man... but to be honest I tend to agree with you in this case... more likely not to see a substantial difference from Z + Zetia.

Just like to thorough with my analysis (i.e. pain in the neck).

Have a good weekend.


condor said...

No, really -- your analysis is very much appreciated!

Thanks, GS!


condor said...

I suppose I should also say -- in my own "pain in the neck" fashion -- that these two can be prescribed NOW, as two separate pills, but taken at the same moment.

That is at least half of my feeling that the two, when simply glued together, appear to be more of a marketing -- than actual medicinal -- play.

[That said, I'll acknowledge the slightly higher patient compliance probability of using a single combo pill. But first, we ought to figure out whether the combo is actually improving outcomes.]

Thanks for sharpening my thinking, GS!


Anonymous said...

Took the words out of my mouth again...

Simply 'glueing' the two pills together, primarily for marketing purposes, but veiled in patient compliance.

BTW, will be at Hyatt Regency June 2, and the Wit on June 3 to 8. Hard to believe I've never really been to Chicago before (Been to 5 different Chinese cities, but not to Chicago). Can you recommend any good Suishi or Asian/Fusion restaurants in C?