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AbbVie (ABBV) Files for Rinvoq in Ulcerative Colitis in US & EU

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AbbVie Inc. (ABBV - Free Report) announced that it has submitted regulatory applications to both the FDA and the EMA (European Medicines Agency), seeking approval for its JAK inhibitor, Rinvoq (upadacitinib), for a new indication. The company is seeking approval for once-daily Rinvoq to treat adult patients with moderate to severe active ulcerative colitis (“UC”).

The regulatory filings for UC were based on data from two phase III induction studies and one maintenance study. Data from these studies showed that higher number of patients who were treated with Rinvoq achieved the primary endpoint of clinical remission as well as all secondary endpoints versus placebo.

The safety profile of Rinvoq that was observed in these studies was similar to its previously known safety profile, with no new safety signal observed.

Shares of AbbVie have increased 0.9% so far this year compared with the industry’s growth of 9.5%.

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While Rinvoq is approved in the United States for rheumatoid arthritis (“RA”), in Europe, the drug is approved for certain patients with RA, active psoriatic arthritis (PsA), atopic dermatitis (“AD”) and active ankylosing spondylitis (“AS”).

The reason why Rinvoq is approved for only one indication in the United States is because the FDA has frequently delayed its decision on the label expansion filings for Rinvoq in AD, active PsA and active AS in adults. The FDA cited the ongoing review of Pfizer's (PFE - Free Report) post-marketing study, ORAL Surveillance, evaluating its marketed JAK inhibitor drug, Xeljanz (tofacitinib), in patients with RA as the reason for the delay. The review on Xeljanz safety study is now complete. Earlier this month, the FDA ordered new warnings to be added on the label of Xeljanz as well as other JAK inhibitor drugs  — Rinvoq as well as Lilly (LLY - Free Report) /Incyte’s (INCY - Free Report) Olumiant. The warning is about an increased risk of serious heart-related events, cancer, blood clots and even death.

The FDA required the warnings to be added not just to Xeljanz’s label, but also on Olumiant and Rinvoq, even though no similar safety study on these two medicines has been conducted. The FDA argued that since they share the same mechanism of action as Xeljanz, they may carry similar risks as identified in Xeljanz’s safety study.

It is likely that the FDA will delay its decision on the sNDA for the UC indication as well, while the European Commission may approve it. Rinvoq generated sales of $681 million in the first half of 2021.

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 was expecting 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. AbbVie expects the combined revenues of these two drugs to be more than $15 billion by 2025. However, with new warnings on Rinvoq’s labels, the company might not be able to meet its sales target for the drug.

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AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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