The FDA officially shot down Merck & Co.'s ($MRK) proposed labeling boosts for Zetia and Vytorin. The cholesterol drugs won't bear the agency's seal of approval for reducing the risk of heart attacks and strokes in patients with heart disease.
Merck had asked for that risk-reduction claim after the IMPROVE-IT study, which found that adding Zetia (ezetimibe) to statin therapy delivered a statistically significant decrease in cardiovascular complications. Vytorin is a combo pill comprising ezetimibe and Merck's off-patent statin drug simvastatin.
But statistical significance isn't significant enough, an FDA panel of outside experts determined late last year. The agency itself followed the panel vote--10-to-5 against--in rejecting the new label.
The panel vote, and now the FDA's ratification of it, dashes Merck's hopes for a new marketing push on its cholesterol franchise.
It could also put a near-term damper on the new generation of PCSK9 cholesterol-fighters, Amgen's ($AMGN) Repatha and Sanofi/Regeneron's Praluent, which analysts had expected to gain from the IMPROVE-IT data. The study had done them a favor by showing an add-on, non-statin drug can cut cardiovascular risks by delivering bigger LDL reductions, or so the theory went. Early data from Repatha and Praluent's own outcomes studies are due later this year.Dr. Milton Packer
For Vytorin and Zetia, the benefits were too small for a label change. "It is not robust. You blink and you miss it," panelist Dr. Milton Packer of Baylor University Medical Center said before the vote in December, "and you wonder if you care or don't care."
Some of the panel members disagreed. At least one said the FDA's role is to determine whether the trial delivered statistically significant results; whether it's clinically meaningful is a question for others, including payers.
Merck had hoped the FDA would concur and approve the label change anyway. That didn't happen, obviously. The company says it's reviewing the letter and will decide on its next steps.
- read the Merck release
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