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17 Aug 2019

Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)

U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).1 RINVOQ is expected to be available in the U.S. in late August 2019.

The FDA approval of RINVOQ is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies. The studies include assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate. RINVOQ is not indicated for methotrexate-naïve patients.

Types of Drugs for treating rheumatoid arthritis (RA)

  • NSAID’s
  • Analgesics
  • DMARD’s
  • Glucocorticoids
  • Biologics
    • TNF-α Antagonists
    • T-Cell Inhibitors
    • CD20 Antigen
    • JAK Inhibitors
    • Anti-IL6 Biologics
  • Others

The global rheumatoid arthritis drugs market is segmented on the basis of drug type and distribution channel. Based on drug type, the market for rheumatoid arthritis drugs is classified into NSAID’s, analgesics, DMARD’s, glucocorticoids, biologics, and others. The biologics segment further includes TNF-α antagonists, T-cell inhibitors, CD20 antigen, JAK inhibitors, and anti-IL6 biologics. RINVOQ (upadacitinib) will be the new entry to JAK inhibitors. 

Competition: There is huge competition in Rheumatoid arthritis market.

  • RINVOQ will compete with Pfizer’s Xeljanz and Eli Lilly’s Olumiant.
  • A Sanofi/Regeneron received approval for their IL-6 drug sarilumab (Kevzara).
  • J&J was permanently shunted aside after the FDA spurned its application on sirukumab over safety concerns.

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