Thursday, December 20, 2012

Ouch! Tredaptive HPS2-THRIVE Study: Fails Primary Endpoint

Well, THRIVE was a large, highly-powered study -- 25,000 subjects. This is definitive, then. And there was a signal of harm from niacin. Goodness.

Indeed, Tredaptive has had a rathered checkered submittal past at FDA -- significantly delayed in 2008; now no longer even being considered by Whitehouse Station -- for an NDA filing here in the States.

It is approved in the EU, if memory serves -- but will now likely see steep declines in revenue, since it appears that it doesn't improve CV outcomes in any statistically significant way. Here it is, per Yahoo news:
. . . .Tredaptive™ (extended-release niacin/laropiprant) did not meet its primary endpoint. Merck and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to work with regulators to provide updated information to health care providers. Based on the current understanding of these new data and until further analyses can be completed, Merck is recommending that providers not start new patients on Tredaptive. Merck does not plan to seek regulatory approval for the medicine in the United States. . . .
The Food and Drug Administration shocked legacy Merck Schering-Plough in 2008 -- by withholding approval of Tredaptive over concerns about the side effects of its key component, niacin.

That seems to have been a sensible move, now that the THRIVE results are known.

Do stay tuned  -- as Merck is off about $1.30 in NASDAQ premarket trading this morning.


Anonymous said...

Tredaptive is a Merck drug, not legacy SP. The harm could be related to the anti-flushing component of Tredaptive.

Condor said...

Oops -- you are of course, correct.

It seems I even wrote as much, back in 2008-2009.

I should look at my own back pages, from time to time, I guess -- before I post.

In any even, thank you!

Do stop back -- Namaste

Condor said...

And -- as expected -- the just-announced review by the EU's Pharmacovigilance Risk Assessment Committee is likely to cause Merck to voluntarily withdraw Tredaptive in Europe.

That's my guess, at least.


Anonymous said...

I left Merck a year ago but was in a clinical support role when MK0524a first entered trials. Very few folks in support roles had much faith in this one actually working out but there was a very 'Top Secret' attitude on this particular program. A colleague was part of the marketing team that rolled it out in the EU and it still had a weird vibe to it. I guess intuition isn't scientific enough to count for anything but this one seemed like it wasn't going to do much from go.

Condor said...

I should follow up here, and note that Matt Herper at Forbes reported yesterday that Merck took the unusual step of sending "Dear Doctor" letters to physicians treating non-US patients with Tredaptive.

The letter indicated that the safety signals (likely related to the niacin component of the combo) included “. . . .statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received TREDAPTIVE and statin compared to the group that received statin without TREDAPTIVE. Preliminary analyses suggest that the events fall within the following broad categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin. Additional analyses are ongoing to understand the adverse events within these categories. . . ."

It is extremely likely that Tredaptive will be voluntarily withdrawn, worldwide, by Merck, at some not too distant future point, IMHO.