Monday, March 5, 2012

FDA: "No, For Now" -- On Lipitor®/Zetia® Combo Pill


Not remotely surprising -- but Merck must now either decide to double-down, and invest anew in the combo-pill (despite the vagaries experienced with the Vytorin® combo-pill), or decide to cut its losses, and move on. Fascinating. [More of my background, here.] From the AP, then:

. . . .The Merck experimental drug combines the company's cholesterol drug Zetia with a generic version of rival Pfizer Inc.'s Lipitor, which had been the top-selling drug of all time.

Merck says company officials will talk with the FDA to determine the next steps for trying to win approval. . . .

This actually may save Whitehouse Station some money in the longer run, if it decides to moth-ball the combo. Obviously, Lipitor® is now a cheap generic, and the jury is still out (IMPROVE-IT -- due 2014) on whether statins (of which Lipitor is one) combined with Zetia® actually improve outcomes, or just lower the numbers, in blood levels, without any overall CV risk reduction effect.

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