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Upadacitinib: First Approval.

Sean Duggan1, Susan J Keam2

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Upadacitinib (Rinvoq™) is a new oral Janus kinase 1 (JAK-1) inhibitor approved for rheumatoid arthritis. It offers a treatment option for patients with moderate to severe disease who have not responded to methotrexate.

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Area of Science:

  • Pharmacology
  • Immunology
  • Rheumatology

Background:

  • Upadacitinib is an orally-administered Janus kinase 1 (JAK-1) inhibitor developed by AbbVie.
  • Rheumatoid arthritis (RA) is a chronic autoimmune disease requiring effective treatment options.

Purpose of the Study:

  • To summarize the development milestones of upadacitinib.
  • To highlight the regulatory approval process for upadacitinib in rheumatoid arthritis.

Main Methods:

  • Review of multinational phase III clinical trial data.
  • Summary of regulatory submission and approval process.

Main Results:

  • Upadacitinib demonstrated positive results in phase III trials for rheumatoid arthritis.
  • Marketing approval was granted in the USA in August 2019.

Conclusions:

  • Upadacitinib represents a significant advancement in the treatment of rheumatoid arthritis.
  • The drug provides a new therapeutic option for patients with inadequate response or intolerance to methotrexate.