Abbvie Inc (ABBV)

[DewDiligence]

FDA approves Rinvoq for second-line psoriatic arthritis:

https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-u-fda-231800396.html

The second-line restriction (following TNF-a treatment in the first line) is a consequence of the label changes for JAK inhibitors generally in inflammatory diseases (#msg-167001417).

Summary of Rinvoq indications in US and EU:

RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers and adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ 15 mg is also approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.