Merck: FDA won't OK its combo cholesterol drug now

March 5, 2012 By LINDA A. JOHNSON , AP Business Writer

(AP) -- Federal regulators have rejected Merck & Co.'s new combination cholesterol drug, which includes a generic version of the mega-blockbuster Lipitor - at least for now.

It's unclear how long the ruling, announced Monday, might delay approval of the drug, as the Food and Drug Administration is requiring additional study data on the compound. It combines generic Lipitor, the top-selling drug of all time, with Merck's cholesterol medicine Zetia.

Approval could boost Merck's sagging cholesterol franchise by essentially replacing its existing combo pill, Vytorin, with one likely to be seen as more powerful. Vytorin sales have been dwindling for a few years due to concerns about how well it works, and now Merck has to contend with patients possibly defecting to the generic versions of Pfizer Inc.'s Lipitor that came on the market at the end of November.

Merck said Monday that company officials will talk with the FDA to determine the next steps, adding that some new data expected later this year may address the FDA's concerns.

Wall Street seemed unfazed by the news, perhaps because the FDA increasingly asks for additional data before approving many new drugs. In morning trading, Merck shares were up 38 cents at $38.31.

The experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke.

Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver.

Zetia, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats.

Vytorin includes Zetia and an older statin, Merck's Zocor, also called simvastatin.

Sales of Vytorin and Zetia both were hurt when Merck, under pressure from a congressional probe, in early 2008 finally released unfavorable results from a study it had hoped would bolster Vytorin sales. Instead, it showed that Vytorin was no better at reducing plaque buildup in neck arteries than just Zocor, which had been available as a cheap generic since 2006. Zetia, also known as ezetimibe, is protected by patent in the U.S. until 2017.

Lipitor, which had peak sales of around $13 billion, is a more powerful statin then Zocor. That could mean that if the new combination is approved, it would be tried by at least some patients who have not been able to get their numbers to their goal with Vytorin or other treatments.

Meanwhile, last year Lipitor maker Pfizer sued, alleging Merck's application for the FDA to approve the Zetia-atorvastatin combination infringed on a Pfizer patent covering atorvastatin.

A Merck spokeswoman said Monday that the lawsuit "has the potential for holding up FDA approval of the product until" the first quarter of 2014.

Explore further: FDA backs Vytorin for kidney disease patients

shares

Related Stories

FDA backs Vytorin for kidney disease patients

October 31, 2011
(AP) -- The Food and Drug Administration says Merck's cholesterol drug Vytorin helps reduce heart attack, stroke and related problems in patients with kidney disease, a potential new use for the blockbuster drug.

US approves India's Ranbaxy to make generic Lipitor

December 1, 2011
Indian pharmaceutical giant Ranbaxy won US regulatory approval to make the first generic version of cholesterol lowering drug Lipitor, a Pfizer product whose patent expired Wednesday.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.