Thanks to the safety scrutiny on the JAK inhibitor class of drugs, AbbVie’s optimism for its Humira follow-on Rinvoq might have shifted from unbridled to cautious.
But in the meantime, the versatile treatment is piling up approvals.
On Wednesday, the FDA expanded Rinvoq’s label for the third time in the last four months, adding ulcerative colitis to its growing list of indications. This nod is for those with moderate-to-severe UC who have not improved or shown intolerance to one or more tumor necrosis factor (TNF) blockers, such as AbbVie's own Humira.
In December, the FDA endorsed Rinvoq for psoriatic arthritis. A month later, a green light came for atopic dermatitis. Rinvoq scored its first approval for rheumatoid arthritis in 2019.
The UC approval is based on efficacy and safety data from three phase 3 trials. In two studies, patients took a 45 mg daily dose for eight weeks, followed by 15 mg or 30 mg daily doses for maintenance.
In separate phase 3 trials called U-Achieve and U-Accomplish, 26% and 33% of Rinvoq patients achieved remission at week 8, respectively, compared with 4% and 5% for the placebo groups. During the maintenance trial, 52% of those who received the 30 mg dose and 42% of those on the 15 mg dose achieved remission at week 52 versus 12% for those on placebo. Additionally, some Rinvoq patients responded as quickly as week two.
The safety profile was consistent with that seen in rheumatoid arthritis and atopic dermatitis patients using Rinvoq.
With Humira facing a patent cliff in the United States in 2023, AbbVie is counting on Rinvoq and psoriasis med Skyrizi to compensate. While Humira rung up sales of $20.7 billion last year, Rinvoq and Skyrizi generated $1.65 billion and $2.94 billion respectively.
In December, when the FDA dialed back Rinvoq’s rheumatoid arthritis approval, limiting its use to those who have not responded to TNF blockers, the company reduced its 2025 sales projection on the drug from $8 billion to $7.5 billion. Wall Street is not as optimistic, pegging Rinvoq’s 2025 sales at $5.5 billion.
The safety scrutiny for JAK inhibitors came after a post-marketing study of Pfizer’s Xeljanz linked the treatment with increased heart disease and cancer risks over TNF blockers in a group of older rheumatoid arthritis patients with underlying cardiovascular risk factors.
Despite the risks being linked to Xeljanz in that study, the FDA investigated the issue as a classwide problem. Rinvoq, plus Pfizer’s follow-on JAK med Cibinqo, Eli Lilly’s Olumiant and Incyte’s Opzelura cream all now carry boxed warnings about major cardiovascular events, blood clots, cancer and death related to JAK inhibitors.