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26 Jul 2017

BMS's Orencia receives second EC approval in less than a year

New approval for treatment of active psoriatic arthritis (PsA).

The European Commission (EC) has approved Bristol-Myers Squibb's (BMS's) Orencia alone or in combination with methotrexate for the treatment of active psoriatic arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate (MTX), has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.

This approval, which allows for the expanded marketing of Orencia as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for Orencia in less than a year; in September 2016, the EC approved Orencia, in combination with MTX, for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which Orencia is approved to treat in Europe.

“This EC approval builds on the well-established profile of Orencia in RA and exemplifies our commitment to ongoing clinical research of Orencia as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications,” said Brian J. Gavin, Vice President, Orencia Development Lead at BMS. “Despite the current availability of medications, there are many people with active psoriatic arthritis who are in need of a new treatment option; the approval of Orencia now provides a novel immunotherapy approach that may help these patients.”

The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with Orencia 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3%, respectively. Responses were seen regardless of prior tumour necrosis factor inhibitor (TNFi) treatment in both studies.

In the Phase III study, PsA-II, the proportion of radiographic non-progressors (≤0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with Orencia 125 mg SC (42.7%) than placebo (32.7%). There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebo-controlled period. The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in RA.

In PsA, the immune system attacks healthy joints and skin. T-cell activation is involved in the pathogenesis of PsA. The costimulation blockade of Orencia inhibits T-cell activation and the resulting cascade of events that contribute to joint destruction. Both IV and SC injection formulations of Orencia are now approved to treat adult patients with active PsA.

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