NEW YORK, Dec 27 (Reuters Health) -- The US Food and Drug Administration
(FDA) has expanded approval of the drug Celebrex (known generically as
celecoxib) to include treatment of people with a rare inherited condition known
as familial adenomatous polyposis (FAP).
People with FAP can develop hundreds of intestinal polyps, and nearly all
who go untreated develop colorectal cancer by age 40 to 50.
Celebrex, a new type of anti-inflammatory drug known as a COX-2 inhibitor,
is the "first drug treatment aimed at reducing the number of intestinal polyps"
in patients with FAP, according to an FDA statement. The drug was first approved
for management of rheumatoid arthritis and osteoarthritis in 1998.
Celebrex "should be used only as an adjunct to usual care in managing
FAP....It is critical that this usual care not be altered," according to the
FDA. Usual care includes surgical removal of all or much of the lower intestine,
followed by regular examinations to check for cancer.
Expanded approval was based on a study of 83 patients with FAP. Those
receiving 400 milligrams of Celebrex had a 28% reduction in polyps, while there
was a 5% reduction in patients receiving a placebo. Side effects included
diarrhea and indigestion.
Accelerated approval has been granted on the condition that the
manufacturer continue to assess the clinical benefits of polyp reduction and the
persistent benefits of treatment after discontinuation of the medication.
