WASHINGTON, June 7 (Reuters Health) - The US Food and Drug Administration
(FDA) has approved Immunex's Enbrel for use as a first line treatment of
moderate to severe rheumatoid arthritis (RA).
First approved in November 1998, Enbrel's use was previously limited to
patients with RA who had not responded adequately to anti-rheumatic drugs.
FDA's clearance was based on the "ERA" study, a multicenter trial with 632
patients with early stage RA who had not received previous treatment with
another arthritis drug, methotrexate.
Study subjects were given either 25 milligrams or 10 milligrams of Enbrel,
or up to 20 milligrams of methotrexate per week for 12 months.
