The European Commission has expanded the approved indications for Bristol-Myers Squibb's biologic Orencia, now allowing its use in patients with highly active and progressive rheumatoid arthritis who have not been previously treated with methotrexate.
The regulator approved Orencia (abatacept) in combination with methotrexate (MTX) back in 2010 for adults with moderate to severe active RA who failed to respond to treatment with one or more disease-modifying antirheumatic drugs (DMARDs), including MTX or a tumour-necrosis factor-α inhibitor.
The drug's expanded clearance, which allows its use much earlier in the treatment pathway, comes on the back of data from two late stage trials in MTX-naive patients.
The Phase III AGREE study met its co-primary endpoints of the proportion of patients taking Orencia plus MTX versus MTX alone achieving DAS28-CRP (a measure of disease activity) of < 2.6 at one year (41 percent vs 23 percent, respectively) and inhibition of radiographic progression at one year (mean change in total Sharp score 0.6 vs 1.1).
The AVERT trial showed that, at 12 months, significantly more patients on Orencia combination therapy achieved DAS28-defined remission than MTX alone (60.9 percent versus 45.2 percent, respectively).
With the expanded clearance, Orencia becomes the first biologic therapy with an indication in the EU specifically applicable to the treatment of MTX-naive patients with RA who have highly active and progressive disease, BMS notes.
The approval is "a testament to Bristol-Myers Squibb's commitment to advancing the science of earlier identification of patients with progressive RA prior to their suffering debilitating joint damage," said Brian Gavin, Orencia development lead at the firm.