FDA Sets a Higher Standard for Merck

Merck (NYSE: MRK  ) finally came clean on what the FDA wants before the drug formally known as Cordaptive (MK-0524A) can be approved. From the looks of it, it's going to be a long wait for Merck.

The Food and Drug Administration rejected MK-0524A back in April, but Merck didn't give much other information -- except that the FDA had rejected the brand name, too. On Friday, Merck elaborated that the FDA wants to see the results of a trial (HPS2-THRIVE) that won't be available until January 2013. That's a serious wait to turn around Merck's cholesterol franchise, which was hurt earlier this year when it and Schering-Plough (NYSE: SGP  ) presented results suggesting that Vytorin doesn't lower plaque in arteries any more than a generic statin.

Ironically, it was likely the Vytorin trial is what spurred the FDA to wait for the results of HPS2-THRIVE. Because Vytorin was approved based on a surrogate endpoint -- lowering bad cholesterol -- but hasn't been proven to save lives, the FDA now appears reluctant to approve MK-0524A based on its ability to raise good cholesterol and instead would like to see the results of HPS2-THRIVE, which will measure MK-0524A's ability to delay a major vascular event, such as a heart attack or a stroke. The shift away from using surrogate endpoints for cholesterol drugs is also delaying Isis Pharmaceuticals' (Nasdaq: ISIS  ) and Genzyme's (Nasdaq: GENZ  ) mipomersen drug from being approved for use in the general population.

It's a little surprising that the FDA would require Merck to wait for an outcomes study, because MK-0524A is a combination of extended-release niacin and laropiprant, and niacin is already approved as a treatment for cholesterol issues. The laropiprant part is a flushing inhibitor that reduces a hot-flash-like side effect of niacin. It's possible that the FDA is worried about the safety of the relatively new laropiprant, but it shouldn't take a trial of 20,000 subjects to detect any safety issues.

Merck has already received a positive recommendation for MK-0524A in Europe, so the drug should hit the market there by the end of the year, I would guess. That's some solace, but Merck's comeback in the cholesterol drug space in the U.S. is going to have to wait a few years.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

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  • Report this Comment On June 23, 2008, at 6:29 PM, jackruster wrote:

    Not only did the FDA set a higher standard, politically based I believe; but their decision directly resulted in Merck eliminating 1200 sales and support positions in the US. Tks FDA...PS 1) Vytorin never made the claim that it would reduce arterial plaque, only that it would significantly reduce LDL and Total Cholesterol better than a Statin alone, which it clearly did. Lower LDL in particular correlates with a reduced risk of a CV event. Zocor, Lipitor etc all have proved this in a number of well documented trials. PS 2) Eventually will come a day when every drug will have a Black Box Warning that will state " This drug will probably help you, but there is a slight chance that you may have an adverse event and even a smaller chance it may kill you, you and your doctor will have to decide if the Benefits outweigh the Risks " When that day comes the Steve Nissens of the world will have to stop being so anti-pharma!

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