Merck’s Liptruzet Wins U.S. FDA Approval to Lower Cholesterol

Merck & Co. won U.S. marketing approval for Liptruzet, a combination of the company’s Zetia pill and a generic version of Pfizer Inc.’s Lipitor, to lower elevated levels of bad cholesterol.

The medicine may benefit patients who aren’t able to get their cholesterol to ideal levels with existing treatments, said Peter Jones, associate professor of medicine at Baylor College of Medicine, in a statement released today by Whitehouse Station, New Jersey-based Merck. The two-drug combination reduced cholesterol 50 percent in studies by blocking absorption in the digestive track and production in the liver.

The Food and Drug Administration approval is a positive turn for Merck, which has struggled with research and development and has four other medicines under regulatory review. Roger Perlmutter, formerly of Amgen Inc., took the helm of the company’s R&D efforts last month after setbacks including the failure to win approval for a sarcoma therapy and the termination of a different cholesterol-lowering drug program.

“This is certainly not a ‘high science’ product, yet there is something to be said for a drug that can boast the best LDL cholesterol lowering of any single oral agent currently available, even better than AstraZeneca Plc’s Crestor,” Timothy Anderson, an analyst at Sanford C. Bernstein & Co. in New York, said today in a note to investors.

Vytorin Connection

The approval may be most significant because of what it could mean for Merck’s Vytorin pill, Anderson said. Vytorin, which combines Zetia with the less-potent agent simvastatin instead of generic Lipitor, is being studied in a closely watched clinical trial to see if it’s safe and more effective at preventing heart disease than standard cholesterol-lowering drugs called statins.

If the FDA was worried about any harm stemming from Vytorin during a current trial, it’s unlikely the agency would approve an even more potent combination pill, Anderson wrote.

“If this logic is right, then the Merck story has just been partially de-risked,” Anderson wrote.

Zetia generated almost $2.6 billion in 2012 global sales while Vytorin brought in about $1.7 billion, according to data compiled by Bloomberg.