NDA Submitted for Investigational Rheumatoid Arthritis Treatment

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The Company is currently assessing the treatment in 6 separate trials; comparing upadacitinib to placebo, methotrexate, and adalimumab, respectively.
The Company is currently assessing the treatment in 6 separate trials; comparing upadacitinib to placebo, methotrexate, and adalimumab, respectively.

AbbVie has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for upadacitinib (ABT-494), their investigational oral treatment for rheumatoid arthritis (RA). 

Upadacitinib is a small molecule JAK1-selective inhibitor being investigated for a range of inflammatory conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis, psoriatic arthritis and axial SpA. The NDA submission was based on data from the SELECT phase 3 RA program that enrolled over 4000 patients with moderate to severe RA across five phase 3 studies. For all studies, upadacitinib met all primary and ranked secondary endpoints. Infections were the most common serious adverse events reported. 

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The Company is currently assessing the safety and efficacy of upadacitinib in 6 separate trials (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426) that compare the treatment to placebo, methotrexate, and adalimumab, respectively. Major efficacy measures include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression.  Preliminary data were included in the NDA submission. 

"If approved, upadacitinib has the potential be a meaningful treatment option for a broad range of rheumatoid arthritis patients. We look forward to working with the regulatory authorities throughout the review process," said Michael Severino, MD, President of AbbVie. 

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For more information visit AbbVie.com.

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