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European Commission approves Orencia for PsA
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The European Commission has approved Bristol Myers-Squibb’s Orencia for patients with active psoriatic arthritis, according to a company press release.
“This [European Commission] EC approval builds on the well-established profile of Orencia in rheumatoid arthritis 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,” Brian J. Gavin, PhD, Orencia development lead at Bristol-Myers Squibb, and colleagues wrote. “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.”
According to the release, Orencia (abatacept, Bristol-Myers Squibb) has been approved alone or in combination with methotrexate for treatment of active psoriatic arthritis in adults who had an inadequate response to previous disease-modifying antirheumatic drug therapy and additional systemic therapy for psoriatic skin lesions is not required.
This approval was based on two randomized placebo-controlled studies that showed intravenous Orencia had ACR20 responses in 47.5% of patients who received an intravenous 10 mg/kg dose, in 19% who received an intravenous placebo dose, in 39.4% who received a subcutaneous 125 mg dose and in 22.3% who received a subcutaneous placebo dose. In addition, the percentage of radiographic non-progressors was 42.7% for 125 mg subcutaneous Orencia and 32.7% for placebo. Furthermore, the safety profile was consistent with the rheumatoid arthritis safety profile.
In Europe, Orencia has already been approved for rheumatoid arthritis and juvenile idiopathic arthritis. The FDA recently approved Orencia for psoriatic arthritis.
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