FDA staffers say Actemra works against RA

Shares of Chugai [1], which is controlled by Roche, jumped on the news that FDA staffers had sounded a distinctly positive note about Actemra for rheumatoid arthritis [2]. Staff comments ahead of an expert committee review typically focus on the most negative aspects of the drug. But staffers say the closely watched therapy appeared to help people with RA and that side effects can be controlled by adjusting the dosage. The FDA's expert committee is scheduled to meet tomorrow to review the drug, one of the biggest new drug candidates we'll see this year.

"This should add to Roche's premium growth potential, and add another asset to the immunology franchise," Deutsche Bank said. A number of analysts have pegged Actemra as a sure-fire blockbuster, with Deutsche Bank among the most conservative with a $778 million estimate for 2012.

- read the report [3] from the Wall Street Journal

Related Articles:
Roche posts new data backing Actemra for RA [2]
Roche seeks FDA approval of RA drug Actemra [4]
Roche sees positive late-stage data on Actemra [5]
New data on Actemra [6]
Chugai seeks Actemra approval [1]