AbbVie ABBV has submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of its JAK inhibitor drug, Rinvoq (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
Axial spondyloarthritis is a chronic inflammatory disease that affects the spine and consists of two sub-groups, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Regulatory applications seeking approval of Rinvoq for AS are already under review in the United States while the drug is approved for this indication in Europe.
AbbVie’s stock has risen 29.6% in the past year compared with an increase of 20.8% for the industry.
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The latest applications seeking approval of Rinvoq for nr-axSpA were based on data from the phase III SELECT-AXIS 2 (Study 2) study in which upadacitinib demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo. In addition, AbbVie also submitted data from two studies of upadacitinib in adult patients with AS in Europe to gain expanded approval for patients who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs).
In the United States, Rinvoq is approved to treat the rheumatoid arthritis (RA) indication. Last month, the FDA approved Rinvoq for its second indication — active psoriatic arthritis (PsA) in adults who have had an inadequate response or intolerance to one or more TNF blockers. The approval for the PsA indication marked the first new approval for Rinvoq by the FDA after the agency issued a Drug Safety Communication (DSC) in September 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 Xeljanz, Rinvoq and Lilly LLY/Incyte (NASDAQ:INCY)’s INCY 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 tumor necrosis factor (TNF) blockers.
In 2021, the FDA did not meet the PDUFA action dates for three additional indications for Rinvoq including PsA, AS and moderate-to-severe atopic dermatitis (AD) due to the ongoing review of the Xeljanz’s safety study.
Rinvoq is a key new drug in AbbVie’s portfolio, which, along with another new drug Skyrizi is gradually lowering AbbVie’s dependence on its main immunology medicine, Humira. AbbVie expects that with many new indications expected to be approved in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023.
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.
Lilly/Incyte’s Olumiant (baricitinib) is approved for treating RA and COVID-19 (hospitalized patients).Baricitinib is approved in Europe 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.
Pfizer’s Xeljanz is a much older drug and is approved to treat RA, PsA, ulcerative colitis and AS.
AbbVie currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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