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AbbVie's (ABBV) Rinvoq Gets FDA Nod for Ulcerative Colitis

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AbbVie Inc. (ABBV - Free Report) announced that the FDA approved its promising JAK inhibitor, Rinvoq (upadacitinib), for a new indication on Mar 16. The drug is now approved for the treatment of moderately to severely active ulcerative colitis (“UC”) in adult patients whose disease had an inadequate response or is intolerant to one or more TNF-blocker.

This marks the fourth approved indication for Rinvoq in the United States and the drug’s first gastroenterology indication.

The latest FDA nod was based on efficacy and safety data from two phase III induction studies and one maintenance study that evaluated Rinvoq (15 mg and 30 mg) for treating UC. Data from these studies showed that a higher number of patients who were treated with Rinvoq achieved the primary endpoint of clinical remission as well as all secondary endpoints versus placebo.

AbbVie is also seeking a label expansion of Rinvoq to include UC patients in Europe.

Rinvoq is approved in the United States for treating moderate-to-severe rheumatoid arthritis (“RA”) in adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (“TNF”) blockers. In December 2021, the FDA approved Rinvoq for its second indication — treatment of adults with active psoriatic arthritis (PsA) who had an inadequate response or intolerance to one or more TNF blockers. This was followed by its label expansion in January 2022 to include atopic dermatitis (“AD”) patients.

Ongoing Label Expansion Studies

AbbVie is evaluating Rinvoq in several clinical stage studies for additional indications. In December 2021, the company announced positive top-line results from a late-stage study, U-EXCEED, evaluating Rinvoq in patients with moderate-to-severe Crohn's disease who had an inadequate response or were intolerant to biologic therapy. Data from the study showed that a significantly higher proportion of patients with moderate-to-severe Crohn's disease treated with Rinvoq achieved both primary endpoints of clinical remission and endoscopic response compared to placebo at week 12.

Please note that U-EXCEED study is the first of the two phase III induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate-to-severe Crohn's disease.

Several phase III studies in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are currently ongoing.

We note that in December 2021, the company updated Rinvoq’s label to include a Drug Safety Communication (“DSC”) issued by the FDA. The FDA limited approved use of the drug to certain RA patients who have not responded or cannot tolerate one or more TNF blockers.

In September 2021, the FDA issued a DSC to include warnings about an increased risk of serious heart-related events, cancer, blood clots and even death, to be added to the label of three JAK inhibitor drugs — including Rinvoq, Pfizer’s (PFE - Free Report) Xeljanz and Eli Lilly (LLY - Free Report) /Incyte’s (INCY - Free Report) Olumiant (baricitinib) — in patients for RA. The decision was based on the FDA’s review of a post-marketing study on Pfizer’s Xeljanz in patients with RA.

Pfizer’s Xeljanz is approved to treat RA, UC, active psoriatic arthritis and ankylosing spondylitis. In January, the FDA approved Pfizer’s JAK inhibitor, Cibinqo (abrocitinib), for the treatment of adults with refractory, moderate-to-severe AD.

Eli Lilly and Incyte’s Olumiant (baricitinib) is approved for treating RA and COVID-19 (hospitalized patients). In Europe, baricitinib is approved for AD and is under review for the same in the United States. Lilly and Incyte’s baricitinib is also under review for severe alopecia areata and in phase III studies systemic lupus erythematosus.

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