Merck's Cox-2 Painkiller to Undergo April FDA Panel Review
Merck's Cox-2 Painkiller to Undergo April FDA Panel Review
Washington, Feb. 25 (Bloomberg) -- Merck & Co., the world's biggest drugmaker, will face a panel of U.S. government advisers in its bid to win approval of the second drug in a new class of painkillers.
The U.S. Food and Drug Administration advisory panel will review Merck's Vioxx drug on April 20, the company said. The FDA usually follows the advice of its expert panels when making approval decisions.
If Merck, as expected, gets a positive review from the panel and wins FDA approval, its Vioxx will compete with Monsanto Co.'s Celebrex, which won FDA approval in December. Celebrex sales to date have made its introduction the second most successful in history, behind only Pfizer Inc.'s impotence drug, Viagra.
Celebrex and Vioxx are so-called Cox-2 drugs, which appear to be gentler on the stomach because they target an enzyme linked to pain and inflammation without blocking a related enzyme that protects the stomach from its own acid. Older drugs hit both enzymes and, as a result, long-term use of some painkillers can lead to ulcers or stomach bleeding.
Whitehouse Station, New Jersey-based Merck announced the news before the market opened. Merck shares fell 1 9/16 to 79 1/2 yesterday.
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