Riquent update
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Higher doses of La Jolla's lupus therapy Riquent (abetimus) are well-tolerated, the firm says Nov. 23. The dosing study was conducted in response to FDA's Oct. 14 "approvable" letter (1Pharmaceutical Approvals Monthly Nov. 1, 2004, p. 13). La Jolla is also enrolling a large Phase III confirmatory trial...
Higher doses of La Jolla's lupus therapy Riquent (abetimus) are well-tolerated, the firm says Nov. 23. The dosing study was conducted in response to FDA's Oct. 14 "approvable" letter ( 1 (Also see "Riquent "Approvable" For Lupus; FDA Says Ongoing Study Could Be Enough" - Pink Sheet, 15 Nov, 2004.) , p. 13). La Jolla is also enrolling a large Phase III confirmatory trial.... |