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