Roche Files BLA For Rheumatoid Arthritis Therapy Actemra
This article was originally published in The Pink Sheet Daily
Executive Summary
The novel interleukin-6 receptor-inhibiting mAb has a projected September 2008 action date.
You may also be interested in...
U.S. FDA Approves Roche/Chugai's Actemra For Second-line RA
Roche Japanese subsidiary Chugai's novel interleukin-6 inhibitor Actemra gained U.S. FDA approval Jan. 8 for treating patients with moderately to severely active rheumatoid arthritis for whom TNF blockers aren't working - a good beginning but still a ways from the first-line indication the pharma sought and still hopes to gain using data from its risk management programs and other sources
Roche Will Use REMS Program Data To Show Actemra Is Safe For First-Line RA
Swiss pharma's Genentech unit announced tocilizumab approval for failed TNF patients Jan. 8, saying it is committed to seek earlier uses with post-marketing data, including data from pharmacovigilance and risk plans as well as clinical studies.
Roche Will Use REMS Program Data To Show Actemra Is Safe For First-Line RA
Swiss pharma's Genentech unit announced tocilizumab approval for failed TNF patients Jan. 8, saying it is committed to seek earlier uses with post-marketing data, including data from pharmacovigilance and risk plans as well as clinical studies.