RINVOQ

批准信原文要点

notifying you, under Section 505(o)(4) of the FDCA… JAK/STAT inhibitors indicated for non-hematological conditions… risk of hypoglycemia, including severe hypoglycemia, in patients with diabetes…

批准信原文要点

These Prior Approval supplemental new drug applications provide for updates to the INDICATIONS AND USAGE section… ulcerative colitis (UC) and… Crohn’s disease (CD)… Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors…

批准信原文要点

This “Changes Being Effected in 30 days” supplemental new drug application provides for… To add … as an alternate site…

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This Prior Approval supplemental new drug application provides for treatment of adults with giant cell arteritis.

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These Prior Approval supplemental NDAs provide for… Update Adverse Drug Reactions (ADRs) incidents rates, • Add pyrexia to Table 7 regarding patients with ulcerative colitis.

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These Prior Approval supplemental NDAs… S-022 provide for… the treatment of patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers, respectively.

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These Prior Approval supplemental NDAs 211675/S-021 and 211675/S-022 provide for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis… and … psoriatic arthritis… respectively.

批准信原文要点

This Prior Approval sNDA provides revisions to the following sections of the U.S. Prescribing Information for Rinvoq, as well as corresponding revisions to the Medication Guide: • Warnings and Precautions 5.1 • Warnings and Precautions 5.10 • Use In Specific Populations 8.1 (Pregnancy) • Patient Counseling Information 17 (Embryo-Fetal Toxicity)

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the US prescribing information (USPI) to include information on improvement in fatigue scores in adult patients with ulcerative colitis treated with Rinvoq.

批准信原文要点

This Prior Approval supplemental new drug application provides for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.

批准信原文要点

This Prior Approval sNDA provides for revisions to the following sections of the U.S. Prescribing Information for Rinvoq, as well as corresponding revisions to the Medication Guide: • Warnings and Precautions 5.10 • Adverse Reactions 6.1 • Drug Interactions 7.1 • Use in Specific Populations 8.4, Pediatric Use • Patient Counseling Information, Administration

批准信原文要点

This Prior Approval supplemental new drug application provides for treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

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This Prior Approval supplemental new drug application provides for the addition of a new indication: Rinvoq (upadacitinib) is indicated for adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

批准信原文要点

This Prior Approval supplemental new drug application provides for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

批准信原文要点

This Prior Approval supplemental new drug application provides for the new indication of the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

批准信原文要点

This Prior Approval sNDA also provides for addition of statement about the higher risk of herpes zoster in patients treated with RINVOQ in Japan to the Warning and Precautions Section 5.1 (Viral Reactivation) as proposed in Supplement 005.

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of the indication of treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers to the prescribing information.

批准信原文要点

notifying you, under Section 505(o)(4)… Janus kinase inhibitor (JAKi) products… increased risks of major adverse cardiovascular events, malignancy, thrombosis, and mortality… This supplemental new drug application provides for revisions to the labeling for Rinvoq (upadacitinib) consistent with our August 23, 2021 safety labeling change notification.

批准信原文要点

This Prior Approval supplemental new drug application provides for minor labeling revisions to Sections 6.1 and 14.