Amgen builds structural damage claims
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen/Wyeth's Enbrel (etanercept) sBLA for "inhibiting the progression of structural damage of active arthritis in patients with psoriatic arthritis" clears FDA Aug. 21. Amgen's interleukin-1 receptor antagonist Kineret (anakinra) also clears FDA Aug. 22 with a supplemental indication for slowing progression of structural damage in moderately to severely active rheumatoid arthritis (1Pharmaceutical Approvals Monthly Nov. 1, 2002, p. 9)...