Whither Cordaptive? Merck May Have A Long Wait
3 CommentsBy Ed Silverman // May 5th, 2008 // 8:37 am
After the FDA rejected the drug, which was to have revived Merck’s cholesterol franchise, its shares plunged. The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a common reaction to niacin. But the drugmaker offered no insights into the rejection, leaving Wall Street to speculate - and the speculation isn’t optimistic.
In an investor note this morning, Catherine Arnold of Credit Suisse writes that the “laropiprant component of Cordaptive presumably had cardiovascular signals. Even though this may have been in very small numbers, the FDA was unable to get past the notion that Merck couldn’t explain why it happened in some patients and not in others, while the potential target population is large.”
She goes on to say the “FDA risk/benefit analysis must have given more weight to theoretical risk and possibly a small rate of actual cardiovascular events. The non-approval may have been cemented by the backdrop which includes the commercial availability of other niacin options and only small differences in study discontinuations favoring Cordaptive.’
And Arnold notes that cardiovascular signals weren’t evident in studies comparing Cordaptive versus a combination of niacin and Zocor, “we do not know if there was a signal in the monotherapy (laropiprant alone) studies, as these are not publicly available.” Here’s a study for background reading.
The upshot: New multi-year studies may be required, because an existing study called HPS2-Thrive won’t evaluate the effect of laropiprant on reducing or increasing cardiovascular signals compared with niacin alone. So Arnold sees this “potential higher burden” a good reason to push out her forecasts for Cordaptive and a combo of Cordpative and Zocor until 2012, at the earliest.
LILLI
I think Merck, Congress, FDA, CDC and any other government asgency involved im medicatiions should not allow new cholesterol medications to be introduced now. NOT UNTIL our elected and appointed representatives make a careful truthful investigation of the sereious dangerous harmful deadly problesm that Zocor has caused.
DrRadius
Zocor (Simvastatin) has not caused any more problems than any other currently marketed statin on the marketplace. In many areas of this country it is now the most used stain more than Lipitor and more than Crestor. Now that Zocor has gone generic it is used more than ever; and managed care has no issue forcing its use in low and moderate risk patients. The highest dose of Zocor has its share of side effects (as do any of the statins) and that is why it is used so infrequently. Zocor is perfectly safe if used properly.
Paul
It baffles me when I observe that drugs are incredibly criticized and blamed for everything under the sun — while they are still single source (i.e. no generic is available).
But then, once they are genericized (usually at the end of their patent life) they are amazing, have no side effects, and are the best things since sliced bread.
yep, Zocor (or simvastatin now) is an excellent drug and has always been. There are no more or less side effects now than when there was no generic.
Yet, products like Vytorin which has mostly Zocor plus a little bit of the fairly safe zetia, are made to look like poison.
Interesting