In a blow for Merck & Co.'s cholesterol franchise, an FDA advisory panel shot down its bid to tout Vytorin and Zetia as preventives against heart attacks and strokes.
Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.
Merck & Co.'s cholesterol drug Vytorin hit its goal in a long-awaited outcomes trial, beating solo statin therapy at cutting cardiovascular risk. It's a vindication for the company, which endured a storm of criticism about an earlier trial in which Vytorin fell short.
Merck & Co. just disclosed some welcome news for its own investors--and potentially for competitors, too. Not to mention all the market watchers ready for the long IMPROVE-IT trial saga to come to an end.
New rules for prescribing statin drugs could double the number of people taking them--or not. They could help AstraZeneca pump up sales of its high-powered Crestor--or not. What they will do--most likely--is undercut Merck's cholesterol drugs Vytorin and Zetia, along with AbbVie's fenofibrate-based lipid meds TriCor and Trilipix.
Merck cut its sales forecast and posted a 50% drop in quarterly earnings as it continues to absorb major hits to its once-blockbuster Singulair. The fact that profits beat analyst expectations says as much about those expectations as it does about Merck's performance for the quarter.
No question, statins are the big gorilla of the cholesterol-fighting drug market. And as Forbes reports today, that drug class is marking out an even bigger territory as time goes by. Over the past 5 years, statin prescriptions have grown by 17% to 214 million a year, while other cholesterol remedies lost 28% of their scripts. Now, those other drugs only account for 50 million prescriptions a year.
Merck will soon launch a new cholesterol combo that melds its Zetia drug with generic Lipitor. The Zetia-plus-statin approach isn't new, of course; Merck already sells Vytorin, a combination of Zetia and its own off-patent statin Zocor, known generically as Simvastatin.
The huge late-stage study that is seeking to determine once and for all if Merck's combo cholesterol drug Vytorin actually works and is safe will run its full course now that an independent safety board has signed off following a review of the data.
The Vytorin outcomes trial will go on. That's all the information we're getting out of the enormous Improve-It study for now. An independent data monitoring board looked at the trial's results so far and recommended that it continue.