The FDA is delaying approval of Roche's new rheumatoid arthritis drug Actemra [1], saying that it wants to see more information on the therapy. The news swiftly hit the share price of Chugai, Roche's partner on the drug. The FDA is looking for more information on manufacturing and the final label. But significantly the agency is not looking for more safety or efficacy data and is not asking for any time-consuming clinical trials.
Analysts widely expect Actemra to compete for blockbuster status with more than a billion dollars in annual revenue. The therapy is one of Roche's most promising new drugs. It blocks the IL-6 protein, which plays a role in inflammation. Despite the delay, analysts voiced their confidence of a pending approval.
- here's Roche's release [2] on Actemra
- read the story [3] from the Wall Street Journal
Related Articles:
Advisory Panel recommends Actemra to FDA [1]
FDA staffers say Actemra works against RA [4]
Roche posts new data backing Actemra for RA [5]
Roche seeks FDA approval of RA drug Actemra [6]
Links:
[1] http://www.fiercepharma.com/story/advisory-panel-recommends-actemra-fda/2008-07-30
[2] http://www.fiercebiotech.com/press-releases/fda-issues-complete-response-letter-roche-actemra-biologics-license-application
[3] http://online.wsj.com/article/SB122175409381952709.html?mod=googlenews_wsj
[4] http://www.fiercebiotech.com/story/fda-staffers-say-actemra-works-against-ra/2008-07-28
[5] http://www.fiercebiotech.com/story/roche-posts-new-data-backing-actemra-for-ra/2008-05-12
[6] http://www.fiercebiotech.com/story/roche-seeks-fda-approval-ra-drug-actemra/2007-11-21