Bristol-Myers Squibb (BMS) obtained approval from the European Commission for Orencia® in combination with methotrexate (MTX) for moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.
Sanction was supported by data from a two-year open-label study in MTX-naïve RA patients (AGREE) as well as by long-term open-label data from clinical trials in MTX inadequate responders (IR) (AIM, ATTEST, and a Phase IIb study) and in anti-TNF-IRs (ATTAIN and ARRIVE). The studies indicate that Orencia may provide improved outcomes in short-term efficacy as well as durable and sustained long-term efficacy (up to seven years as demonstrated in the Phase IIb study) when used with MTX earlier in the RA treatment paradigm. In addition, a sustained reduction in the rate of progression of structural damage up to five years was demonstrated in the AIM trial.
Orencia is a selective co-stimulation modulator of T-cell activation. It is designed to prevent full T-cell activation and inhibit the release of chemicals leading to joint inflammation and destruction as observed in RA and polyarticular juvenile idiopathic arthritis (pJIA), according to BMS.
The European Commission first green-lighted the drug in May 2007 for adult RA. This January it gave Orencia in combination with MTX the go-ahead for moderate-to-severe active pJIA in pediatric patients six years and older who have had an insufficient response to other DMARDS including at least one TNF-alpha inhibitor.
Initial FDA approval came in December 2005. The agency sanctioned the therapy for reducing the signs and symptoms of RA, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderate-to-severe active RA who have had an inadequate response to one or more DMARDs. In April 2007, Orencia’s label in the U.S. was strengthened from “slowing” to “inhibiting” the progression of structural damage in these patients. In April 2008, BMS gained approval for Orencia in the pJIA indication for patients six years or older.