Abbvie’s RA Drug Moves a Step Closer for Approval
Upadacitinib developed by Abbvie is a step closer towards marketing as a rheumatoid arthritis (RA) treatment. The US FDA has accepted and granted Priority Review to AbbVie’s New Drug Application (NDA) for upadacitinib as a therapy for adult patients with moderate to severe RA. The oral drug which is a Janus kinase 1 (JAK1) inhibitor is expected to receive FDA regulatory decision for RA in the second half of 2019. AbbVie submitted the NDA with supporting data from the SELECT phase-3 program where 4000-plus adults with moderate to severe RA were included across 5 studies. The studies included safety, efficacy and tolerability across a broad range of patients with RA.
Investigators from the phase-3 SELECT-MONOTHERAPY trial showed that patient-reported outcomes including joint pain, physical function, morning stiffness and health-related quality of life were significantly improved in patients with moderate to severe RA who previously did not respond adequately to methotrexate in data presented at the ACR/ARHP Annual Meeting in Chicago in October 2018. The findings significant for the patients who had failed to report such improvements while on previous monotherapies such as methotrexate. Investigators noted that joint pain improvements were reported in some patients administered either 15 mg or 30 mg upadaticinib as soon as two weeks and by week 14, 65% and 69% on the therapy doses, respectively, had reported physical function improvements, compared to 45% of those administered with methotrexate.
AbbVie vice president of Global Immunology Development Marek Honczarenko, MD, PhD, said "Upadacitinib as a monotherapy showed significant improvements in rheumatoid arthritis patients' ability to perform daily activities and overall health-related quality of life". He also added, “These results show that the improvements in clinical symptoms are accompanied by improvement in outcomes important to patients. These results reinforce upadacitinib's therapeutic potential across diverse rheumatoid arthritis patient populations and its use as a monotherapy treatment option." The therapy is also currently being explored as a treatment for psoriatic arthritis, Crohn’s disease atopic dermatitis, and ulcerative colitis in phase-3 trials.
- Arpitha Shetty,