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FDA Approves Enbrel Plant in Rhode Island

Amgen and Wyeth Pharmaceuticals announced on Dec. 23, 2002, the U.S. Food and Drug Administration (FDA) approval of their new Rhode Island manufacturing facility for Enbrel.

With the plant approval, the company expects to meet all future demand for Enbrel. An estimated 40,000 people were on a waiting list for Enbrel; the list was cleared in mid-December when the German plant produced enough of the drug to meet patient needs. The Rhode Island facility will solidify Amgen's ability to fulfill new orders.

Enbrel is one of many "biologic response modifiers" that have been in development and testing for psoriasis and psoriatic arthritis. This new class of drugs is genetically engineered to block key interactions between cells in the immune system involved in these diseases. Other treatments for and psoriatic arthritis, particularly those used in moderate to severe cases, can have a widespread impact on the immune system.

Enbrel is also approved for rheumatoid arthritis, a destructive bone disease with similar symptoms to psoriatic arthritis, and juvenile rheumatoid arthritis (which affects young people).

Prior to being prescribed Enbrel, people are still required to join an enrollment program; enrolling means receiving forms to verify insurance coverage and that a physician must also sign. The number for the program is (888) 436-2735.