AbbVie Inc. ( ABBV Quick Quote ABBV - Free Report) announced that the FDA has approved its promising JAK inhibitor, Rinvoq (upadacitinib), for a new indication. The drug is now approved for the treatment of moderate to severe atopic dermatitis (“AD”) in adults and children aged 12 years and above whose disease did not respond to previous treatment and is not well controlled by other pills or injections, including biologic medicines, or when use of other pills or injections are not recommended. This marks the third approved indication for Rinvoq in the United States.
The latest FDA nod was based on efficacy and safety data from one of the largest registrational phase III programs that evaluated Rinvoq (15 mg and 30 mg) for AD in more than 2,500 patients across three studies.
In the studies, treatment with Rinvoq resulted in significant improvement in itch as early as week one and significant improvement in skin clearance as compared to placebo at 16 weeks. Also, treatment with Rinvoq led to significantly higher levels of skin clearance versus placebo at 16 weeks.
Rinvoq (15 mg) is approved in the United States for treating moderate-to-severe rheumatoid arthritis (“RA”) in adults who has 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.
Shares of AbbVie have rallied 23% in the past year compared with the
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Last month, AbbVie announced an
update to the prescribing information for Rinvoq for the treatment of adults with moderate-to-severe RA. The update followed a Drug Safety Communication (“DSC”) issued by the FDA in September 2021. Per the new label update for Rinvoq, the FDA has 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
Pfizer’s ( PFE Quick Quote PFE - Free Report) Xeljanz, Rinvoq and Eli Lilly ( LLY Quick Quote LLY - Free Report) / Incyte’s ( INCY Quick Quote 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. The FDA limited the use of the JAK inhibitor drugs to certain patients who have not responded to or cannot tolerate one or more TNF blockers. Last year, the FDA delayed decisions for three additional indications for Rinvoq, including PsA, ankylosing spondylitis (“AS”) and moderate-to-severe AD, due to the ongoing review of the Xeljanz’s safety study.
In Europe Rinvoq is approved for treating four indications — RA, AD, PsA and AS. It is under regulatory review in the United States as well as Europe for ulcerative colitis. Rinvoq is also being studied in late-stage studies for Crohn’s disease and giant-cell arteritis.
Pfizer’s Xeljanz is approved to treat RA, PsA, ulcerative colitis and AS. Last week, the FDA approved Pfizer’s JAK inhibitor, Cibinqo (abrocitinib), for the treatment of adults with refractory, moderate-to-severe AD.
Eli Lilly/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/Incyte’s baricitinib is also under review for severe alopecia areata and in phase III studies systemic lupus erythematosus.
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