FDA approves Abatacept for juvenile idiopathic arthritis

April 14, 2008

The Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Abatacept. The treatment is indicated for patients 6 and older with moderate-to-severe polyarticular juvenile idiopathic arthritis.

The Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Abatacept. The treatment is indicated for patients 6 and older with moderate-to-severe polyarticular juvenile idiopathic arthritis.

A three-part study of patients ages 6 to 17 who had an inadequate response to disease-modifying anti-rheumatic drugs tested the efficacy of Abatacept. These patients all had subtypes of juvenile idiopathic arthritis.

There were improved responses during the open-label lead-in, which was followed by the randomized, placebo-controlled part of the trial. Patients treated with Abatacept had statistically significant improvement in time to occurrence of disease flare compared with patients receiving placebo, as well as significantly fewer disease flares.

These results remained consistent in the study's third part, an open-label extension.