AbbVie Updates U.S. Label for RINVOQ® (upadacitinib) in Rheumatoid Arthritis with New Safety Information

Dec 13, 2021 00:59 CST Updated 00:59

AbbVie

Innovative Drug Developer

FDA

U.S. Food and Drug Administration

RA-Rheumatoid Arthritis (Image Source: rheumatologyadvisor.com)

December 12, 2021 /BIOON/ -- AbbVie recently announced an update to the U.S. prescribing information and medication guide for Rinvoq (upadacitinib), an oral JAK1 inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA) in adults. This update follows a Drug Safety Communication (DSC) issued by the U.S. FDA on September 1, 2021, after completing the final review of the post-marketing study ORAL Surveillance of Pfizer's oral JAK inhibitor Xeljanz (tofacitinib) for RA treatment.

Results from the ORAL Surveillance study show,Xeljanz (a JAK inhibitor) has higher incidence rates of major adverse cardiac events (MACE), malignancies, death, and thrombosis compared to TNF blockers.. This DSC and this label update,JAK class drugs approved by the FDA for systemic treatment of RA and other inflammatory diseases。

Based on the update of JAK-class drugs, the U.S. label for Rinvoq will now include additional information regarding the risks of malignancy and thrombosis, as well as an increased risk of mortality and MACE (defined as cardiovascular death, myocardial infarction, and stroke) added to the black box warning and the Warnings and Precautions section. The indication for Rinvoq has also been updated as follows: Rinvoq is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.

Currently, the U.S. FDA is still reviewing Rinvoq's supplemental New Drug Applications (sNDAs) for atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC).

AbbVie President and Vice Chairman Michael Severino, M.D., said: "Rinvoq is an important treatment option for adult patients with rheumatoid arthritis, especially those who have not achieved remission or low disease activity. We remain committed to continuing to seek evidence supporting the benefit-risk profile of Rinvoq across a range of inflammatory conditions."

Rinvoq's active pharmaceutical ingredient is upadacitinib, an orally administered, selective, and reversible JAK1 inhibitor discovered and developed by AbbVie. It is being developed for the treatment of several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a critical role in the pathophysiological processes of various inflammatory diseases.

As of now,In the EU, Rinvoq 15mg has been approved for four indications.: (1) For the treatment of adult patients with moderate to severe rheumatoid arthritis (RA); (2) For the treatment of adult patients with active psoriatic arthritis (PsA); (3) For the treatment of adult patients with active ankylosing spondylitis (AS); (4) For the treatment of adult patients and adolescent patients aged 12 years and older with moderate to severe atopic dermatitis (AD). In the EU, Rinvoq 30mg has been approved for one indication: for the treatment of adult patients under 65 years of age with moderate to severe AD.

In the United States, Rinvoq 15mg has been approved for only one indication.: For the treatment of adult patients with moderate to severe rheumatoid arthritis (RA).

Currently, the phase 3 clinical trials of Rinvoq for the treatment of ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PsA), atopic dermatitis (AD), axial spondyloarthritis (axSpA), Crohn's disease (CD), and giant cell arteritis (GCA) are ongoing. (Bioon.com)

Source of Original Text:AbbVie Provides Update on RINVOQ® (upadacitinib) for the Treatment of Rheumatoid Arthritis in the U.S.

Results from the ORAL Surveillance study show,Xeljanz (a JAK inhibitor) has higher incidence rates of major adverse cardiac events (MACE), malignancies, death, and thrombosis compared to TNF blockers.. This DSC and this label update,JAK-class drugs approved by the FDA for systemic treatment of RA and other inflammatory diseases。