Actemra

Blockbuster RA drug wins FDA panel vote

John Carroll — Wed, 30 Jul 2008 11:22:15 -0400

In a near unanimous vote, an FDA expert committee has endorsed Roche's Actemra for approval for use against rheumatoid arthritis. The 10-1 vote moves the drug one more critical step closer to a likely FDA approval of a drug that is a serious contender for blockbuster status.

"Based on the strength of the data presented, and the positive recommendation by the committee, we are hopeful that the FDA will approve Actemra for the treatment of RA and provide a new option to patients who are not achieving adequate symptom relief with current therapies," said Kenneth Bahrt, M.D., Roche's global medical director, autoimmunity.

- read the press release

FDA staffers say Actemra works against RA

John Carroll — Mon, 28 Jul 2008 12:44:01 -0400

Shares of Chugai, which is controlled by Roche, jumped on the news that FDA staffers had sounded a distinctly positive note about Actemra for rheumatoid arthritis. 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 from the Wall Street Journal

Roche posts new data backing Actemra for RA

Mon, 12 May 2008 06:59:54 -0400

Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Researchers say their fifth Phase III trial demonstrated that the therapy inhibited structural damage to joints. And physical function was improved in patients after a year of treatment.

Actemra is widely viewed as one of the three most important late-stage RA drugs in the global pipeline. The wave of late-stage therapies includes Cimzia (certolizumab) and golimumbab, both angling for near-term FDA approvals in the hope of joining the group of anti-TNF therapies on the market. Actemra (tocilizumab) is in a new, non-TNF category that is an odds on favorite to gain approval as a second- or third-line treatment.

- here's Roche's release
- read the AFX report