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FDA advisory panel backs Celebrex for bowel polyps
BETHESDA, Md., Dec 14 (Reuters) - A federal advisory panel said Tuesday the fast-selling painkiller Celebrex should be approved as a treatment for a rare hereditary disease that leads to colon cancer.
Celebrex, co-marketed by Monsanto's G.D. Searle (NYSE:MTC - news) and Pfizer Inc. (NYSE:PFE - news), appears safe and effective for reducing the number and size of pre-cancerous colon polyps in patients with familial adenomatous polyposis (FAP), members of a Food and Drug Administration advisory panel said.
About 1 in 10,000 Americans have FAP, a disease in which hundreds or even thousands of polyps grow in the colon or rectum and eventually turn cancerous. With no drugs yet approved, patients rely on surgery to remove the polyps, but still face a high risk of dying from the disease.
Celebrex hit the market in January and was billed as a safer alternative to aspirin for relieving pain and inflammation from arthritis. Sales got off to a brisk start, hitting $1 billion in October.
The drug inhibits the COX-2 enzyme, which researchers said plays a role in development in certain cancers. Merck and Co.'s (NYSE:MRK - news) Vioxx, the only other COX-2 inhibitor now sold, also is being studied in cancer.
The FDA usually follows its panels' advice. |
