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.
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.
For more information visit AbbVie.com.