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AbbVie (ABBV) Rinvoq Dermatitis' sNDA Decision Delayed by FDA

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AbbVie Inc. (ABBV - Free Report) announced that the FDA failed to give its decision on the supplemental new drug application (sNDA) for its JAK inhibitor drug, Rinvoq (upadacitinib), on the Prescription Drug User Fee Act (“PDUFA”) action date. The sNDA is seeking approval of the drug for treating moderate to severe atopic dermatitis (“AD”) in adults and adolescents.

The FDA informed AbbVie that it is currently reviewing Pfizer’s (PFE - Free Report) post-marketing study, ORAL Surveillance, on marketed JAK inhibitor, Xeljanz (tofacitinib), in patients with rheumatoid arthritis, which it cited as the reason for the delay. We remind investors that in February, the FDA issued a statement that Xeljanz may increase the risk of heart-related problems and cancer.

Last month, the FDA took a similar decision on the sNDAs for Rinvoq for treating active psoriatic arthritis and active ankylosing spondylitis in adults. Back then, the regulatory body cited the same reason for the delay.

This is the second time that the FDA has delayed its decision on expanded use of Rinvoq for the AD indication.

We remind investors that, in April 2021, the FDA extended the review period for the Rinvoq sNDA for AD by three months as the regulatory body needed extra time to review the new data that AbbVie had submitted. The company had submitted information regarding an updated assessment of the benefit-risk profile for Rinvoqin atopic dermatitis, per the FDA’s request.

Shares of AbbVie have rallied 9.7% so far this year compared with the industry’s growth of 9.9%.

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Rinvoq is presently approved for treating moderate to severe rheumatoid arthritis in the United States and Europe. The drug is also approved for treating psoriatic arthritis and ankylosing spondylitis in Europe.

Meanwhile, that European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has also recommended approval of Rinvoq for adults and adolescents with moderate to severe AD.

On Friday, Lilly (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that the FDA will not be able to meet the PDUFA date on their sNDA seeking approval of their JAK inhibitor drug Olumiant (baricitinib) for AD due to the ongoing assessment of JAK inhibitors.

In April 2021, the regulatory body also extended the review timeline of Pfizer’s NDA for abrocitinib, an investigational oral JAK inhibitor for moderate to severe AD, by three months.

The extension of review periods for sNDAs and other negative updates about JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs. However, this class of drugs comes with its share of side effects, including risk of serious infections, malignancies and thrombosis. Some of these side effects are mentioned as boxed warnings in labels of marketed JAK inhibitor drugs.

Zacks Rank

AbbVie currently carries 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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