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FDA Orders Warnings on Pfizer, Lilly, AbbVie JAK Drug Labels

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The FDA issued a directive that the labels of three JAK inhibitor medicines, approved to treat certain chronic inflammatory conditions, should include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death. These three drugs are Pfizer’s PFE Xeljanz/Xeljanz XR, Lilly LLY/Incyte’s INCY Olumiant (baricitinib),and AbbVie’s ABBV Rinvoq (upadacitinib). In addition, the FDA is limiting all approved uses of these three medicines to certain patients who have not responded or cannot tolerate one or more tumor necrosis factor (TNF) blockers.

JAK inhibitors work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by DMARDs. However, this class of drugs comes with their 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 these JAK inhibitor drugs.

The FDA’s latest decision came in the light of the completion of the review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on its marketed JAK inhibitor medicine, Xeljanz in patients with rheumatoid arthritis (“RA”). We remind investors that in February, the FDA had issued a statement that Xeljanz may increase the risk of heart-related problems and cancer based on data from the post-marketing study. The study compared Xeljanz to another class of drugs — TNF inhibitors. The post-marketing safety study failed to show the non-inferiority of Xeljanz to a TNF inhibitor with regard to major adverse cardiovascular events and malignancies.

The FDA’s review of the final data from the study showed that patients treated with both low as well as high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. Previously, the FDA thought that only a higher dose of Xeljanz would increase such risks.

In the United States, Xeljanz is presently approved for four indications, RA, active psoriatic arthritis (PsA), ulcerative colitis (UC),and active polyarticular course juvenile idiopathic arthritis.

The FDA required the warnings to be added not just to Xeljanz’s label but also on Olumiant (baricitinib) and Rinvoq (upadacitinib) even though no similar safety studies on these two medicines have 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. Both Olumiant and Rinvoq are approved for the RA indication in the United States.

However, the labels of two other JAK inhibitor medicines, Incyte/Novartis’ NVS Jakafi (ruxolitinib), and Bristol-Myers’ BMY Inrebic (fedratinib) are not required to be updated for such warnings as these drugs are approved for treating blood disorders and not for arthritis and other inflammatory conditions.

JAK inhibitor drugs have been surrounded by controversies for some time now. The FDA has in the past year delayed its decision on the supplemental new drug applications (sNDAs)/supplemental biologics license applications (sBLA) seeking expanded approval of Xeljanz for ankylosing spondylitis (AS), Olumiant and Rinvoq for moderate-to-severe atopic dermatitis (AD),and also sBLAs on Rinvoq for PsA and active ankylosing spondylitis in adults. The FDA also delayed the decision on Pfizer’s investigational medicine, abrocitinib, also a JAK inhibitor drug, for AD. It cited its ongoing review of safety data from Pfizer’s ORAL Surveillance study as the reason for all such delays.

The FDA’s latest decision to include warnings on labels of Xeljanz, Olumiant, and Rinvoq hit AbbVie’s stock the hardest. AbbVie’s stock declined 7% on Wednesday to a three-month low.

Pfizer is a huge company and Xeljanz accounts for just 3% of its total revenues. The tough boxed warning and its restricted use will undoubtedly hurt sales of Xeljanz but the pharma giant has several other medicines in its portfolio to make up for the lost sales from Xeljanz. In a similar way, Olumiant also accounts for a small fraction of Lilly’s top line.

However, Rinvoq is one of the two key medicines in AbbVie’s portfolio that it believed had the potential to replace sales of its blockbuster drug, Humira (treats a number of inflammatory conditions) when its generics are launched in the United States in 2023. Rinvoq sales, until now, were above management’s expectations and the company was expecting that with many new indications coming up in the next couple of years, sales of the drug could be higher in the future quarters. However, the target now seems difficult to achieve with new warnings on Rinvoq’s label.

Pfizer, Lilly, and AbbVie carry 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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