FDA Advisors Back Drug to Fight Arthritis

A Food and Drug Administration panel on Wednesday unanimously recommended approval of a novel, genetically engineered drug to treat advanced rheumatoid arthritis, saying it significantly helps sufferers combat the crippling disease.

Immunex Inc.’s Enbrel should be approved for patients who get no relief from current drugs, the panel of scientists said.

Enbrel also appeared to cause far fewer side effects than currently available drugs, which can attack patients’ livers and cause vomiting and other problems.

The advisors demanded that Immunex study long-term side effects because the drug works in a unique way: It changes the immune system in a manner that theoretically could risk infections or possibly even cancer. So far, experts say there are no early problems.

Enbrel does not cure rheumatoid arthritis; patients who stopped taking the drug saw their disease immediately rebound.

Clinical trials showed the drug significantly, and in some cases dramatically, improved patients’ symptoms: painful, swollen joints so stiff that the sufferers sometimes can’t move.

The FDA is not bound by its advisors’ recommendations, but usually follows them.