Approval Comes Following Previous FDA Crackdown on JAK Inhibitors
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
The FDA recently approved the JAK inhibitor Rinvoq for treatment in patients with moderate to severe atopic dermatitis who have failed or are not suitable for other treatment options.
According to this January 2022 article, "The wait is over: AbbVie's Rinvoq chalks up FDA win with favorable atopic dermatitis label", this additional indication approval comes despite some safety pushback from the FDA on the JAK inhibitor drug class, which includes Rinvoq, Xeljanz. and Olumiant:
Despite the risks being linked to only Xeljanz, the FDA saw it as a classwide problem. Rinvoq, Pfizer’s follow-on JAK med Cibinqo, Eli Lilly’s Olumiant and even Incyte’s Opzelura cream now all carry similar boxed warnings about major cardiovascular events, blood clots, cancer and death related to JAK inhibitors.
After a safety update in December, the FDA has waved through Rinvoq in psoriatic arthritis and Xeljanz in ankylosing spondylitis with post-TNF restrictions. Also on Friday, Cibinqo got its eczema nod with a label similar to that of Rinvoq’s in the indication.
However, this new Rinvoq treatment approval from the FDA comes with some restrictions. The same January 2022 article, "The wait is over: AbbVie's Rinvoq chalks up FDA win with favorable atopic dermatitis label", states:
Although the FDA label doesn’t yet include that phase 3b data, the approval of the 30-mg dose opens the door for doctors to treat patients with a more efficacious version of Rinvoq—but not before they’ve tried Dupixent and other meds. The high dose is also restricted to patients younger than 65 years of age on top of the indication-wide limitation to patients who’re refractory to other systemic therapies.
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As mentioned in our previous blog post, "Black Box Warning Label Added to JAK Inhibitors Including Xeljanz, Rinvoq, and Olumiant", this recent Rinvoq label approval may be seen as a shift from the FDA's previous stance on JAK inhibitors in view of the FDA required "Black-Box" warning on the respective drug labels for Pfizer's Xeljanz, AbbVie's Rinvoq, and Lilly's Olumiant. At that time,
At the present time, our law firm is investigating Xeljanz, Rinvoq, and Olumiant lawsuits for patients using a JAK inhibitor then developing heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as lymphoma, lung cancer, and other cancers. Please feel free to contact us if we can help you or someone you know with a Xeljanz, Rinvoq, or Olumiant drug injury case.
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