Reading the Enbrel panel's message

WASHINGTON - While last week's endorsement of Immunex Corp.'s Enbrel in rheumatoid arthritis by the FDA's Arthritis Advisory Committee was good news for the company and for sponsors of other biological modifiers, it also highlighted the panel's unease and worries about biological agents. Centocor Inc. (CNTO) and other companies that plan to submit RA products to the panel were given strong clues about what it will take to overcome trepidation about the widespread long-term use of the agents.

Little that IMNX or FDA told the panel indicated that there are serious safety problems associated with Enbrel, a TNF inhibitor(see BioCentury Extra, Sept. 17). And none of the known adverse effects approach the problems caused by methotrexate, a leading treatment for RA, or other treatments...