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news.Bristol-Myers Squibb has said the FDA has approved an update to its Orencia product labeling regarding the progression of structural joint damage, an important measure in the treatment of rheumatoid arthritis.
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The indication was strengthened from “slowing” to “inhibiting” the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying, anti-rheumatic drugs, such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.
Orencia is a selective co-stimulation modulator of a signal required for full T-cell activation and works in a fundamentally different way than cytokine antagonists, including TNF antagonists.
The labeling change is supported by two-year radiographic data from the phase III trial, which met the co-primary endpoints. 56% of Orencia/MTX-treated patients had no progression during the first year compared to 45% of placebo/MTX-treated patients. Progression of structural damage in Orencia/MTX-treated patients was further reduced in the second year of treatment. Following two years of treatment with Orencia/MTX, 51% of patients had no progression of structural damage.