Facility Ok'd

FEBRUARY 01, 2003

More than 1 million patients with rheumatoid arthritis (RA), juvenile RA, and psoriatic arthritis in the United States are candidates for etanercept, and a new 250,000-square-foot structure with its eight 8000-liter bioreactors uses recombinant DNA technology to produce it. The facility, located in Rhode Island, was recently approved by the FDA.

Kevin Sharer, chief executive officer of Amgen, said, ?The facility is among the most advanced cell culture manufacturing centers in the world.?? Joseph Mahady, president, North America, Wyeth Pharmaceuticals, added, ?We believe this FDA approval, combined with 5 years of outstanding clinical performance and tolerability, will encourage physicians to ? make the drug their first choice for patients.? Etanercept acts by binding tumor necrosis factor (TNF), 1 of the dominant inflammatory cytokines (regulatory proteins) that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process of psoriatic arthritis and RA. The binding of the drug to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.

?Etanercept is a very important treatment option,? said Larry W. Moreland, MD, of the University of Alabama.?It is the biologic with the most extensive clinical data in treating rheumatic diseases, leading to the broadest range of indications.? As the only fully human anti-TNF receptor approved for use to reduce the symptoms of active arthritis, it is a drug about which pharmacists are likely to hear a great deal more.



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