EU Approves BMS’ Orencia for Methotrexate-naive RA Patients

bmsEuropean Commission expanded approved indications for Bristol-Myers Squibb’s biologic Orencia, thereby allowing its use in patients with highly active and progressive rheumatoid arthritis that have not previously been treated with methotrexate.

In the past the European regulator approved Orencia in combination with methotrexate in 2010 for adults who have moderate to severe active RA that had failed to respond to treatment with one or more disease-modifying antirheumatic drugs, including MTX or a tumour-necrosis factor-α inhibitor.

The drug’s expanded clearance not only allows its use much earlier in the treatment but also 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 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 used in the EU specifically to treat MTX-naive patients with RA who have highly active and progressive disease, BMS notes.

The approval has been hailed as “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.


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