Monday, December 17, 2007

Merck Continues Plans with Experimental Drugs

After touting its $4.85 billion Vioxx settlement as "a good and responsible agreement," Merck plans to continue with experimental cholesterol and obesity drugs. Anacetrapib, a developing cholesterol drug, is similar to Pfizer’s drug, torcetrapib, which failed after a study demonstrated increased death risks. Merck plans to submit its obesity drug, taranbant, for FDA approval next year. A similar drug called rimonabant, produced by Sanofi-Aventis, was rejected by the FDA earlier this year for psychiatric side effects. Wall Street Journal has a report (subscription required). The Wall Street Journal also reports that the FDA rejected Merck’s recent bid to sell Mevacor, a cholesterol drug, over the counter. Here’s an excerpt:

A Food and Drug Administration advisory committee, for the third time, rejected Merck & Co.'s bid to sell the cholesterol drug Mevacor without a prescription, saying it wasn't clear that consumers would use the medication correctly.

The 10-2 vote leaves little hope Merck can win regulatory approval. It is also a setback for GlaxoSmithKline PLC, which has bought the U.S. over-the-counter marketing rights to the drug. The decision is the latest sign of the regulatory hurdles blocking such switches, at least when a medication treats a complicated condition without obvious symptoms. The FDA typically follows the advice of its expert panels.


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