FDA to review rheumatoid arthritis drug for pediatric use

August 23, 2007

Bristol-Myers Squibb (BMS) said the FDA has agreed to review the company’s supplemental biologics license application for its arthritis drug, abatacept (Orencia). The drug is currently used by adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response to one or more anti-rheumatic medications. [more]

Bristol-Myers Squibb (BMS) said the FDA has agreed to review the company’s supplemental biologics license application for its arthritis drug, abatacept (Orencia). The drug is currently used by adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response to one or more anti-rheumatic medications. [more]

BMS is requesting that abatacept be approved for pediatric patients with juvenile idiopathic arthritis who have had an inadequate response to one or more anti-rheumatic drugs. In support of its application, the company is using data from a double-blind, randomized clinical trial with participants who range in age from 6 to 17 years.