Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
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The U.S. Food and Drug Administration greenlit AbbVie’s Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and juveniles 12 years of age and older who have not responded to previous treatment options or when other options are not advised.
Under the approval, Rinvoq 15 mg can be provided once per day to adults and children 12 years of age and older, weighing at least 40 kg. In children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.
The FDA issued the expanded approval for Rinvoq at the same time Pfizer won approval in the same indication for its JAK inhibitor, Cibinqo (abrocitinib). Like Cibinqo, AbbVie‘s Rinvoq is a small molecule JAK inhibitor. AbbVie has eyed the drug as a potential successor to its blockbuster drug Humira, which has been the primary driver of revenue for the Illinois-based company.
However, there are now concerns about the potential earnings for JAK inhibitors based on new safety warnings placed by the FDA on that class of drugs. As BioSpace previously reported, the FDA decision came after a review of a post-marketing study on Pfizer’s Xeljanz (tofacitinib), another JAK inhibitor.
Data from that study revealed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in patients who received Xeljanz. Following that review, the regulatory agency issued a mandate to update the warning labels of JAK inhibitors to include the latest safety issues. Blood clots and lymphoma are already listed as boxed warnings for this class of drugs.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. Of those, 52% had prior exposure to systemic atopic dermatitis treatment. The studies met all primary and secondary endpoints. In all three studies, patients treated with Rinvoq experienced a significant improvement in itch as early as week one, compared to placebo.
Thomas Hudson, senior vice president of research and development and chief scientific officer at AbbVie, said that when he was a practicing allergist, he would see patients who experienced the relentless itch associated with severe atopic dermatitis, as well as the rash.
“This additional approval for Rinvoq provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It’s also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions,” Hudson said in a statement.
The latest approval for Rinvoq comes weeks after the FDA approved the medication for the treatment of adult patients who have active psoriatic arthritis whose disease has not had an inadequate response or demonstrated intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq was first approved as a treatment for rheumatoid arthritis in 2019. It has also received regulatory approval for the treatment of active psoriatic arthritis and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.
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