USA – AbbVie has announced that the FDA has expanded Rinvoq (upadacitinib) approval to include the treatment of adults with moderate-to-severely active ulcerative colitis (UC) who have had insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The oral JAK inhibitor is now approved for four indications, including rheumatoid arthritis, active psoriatic arthritis, and atopic dermatitis in the United States.

Rinvoq was approved by the FDA for the treatment of psoriatic arthritis in December. A month later, the atopic dermatitis was given the all-clear. Rinvoq received its first rheumatoid arthritis approval in 2019.

The UC approval is based on efficacy and safety data collected from three phase 3 trials. In two studies, patients received a 45 mg daily dose for eight weeks, followed by maintenance doses of 15 mg or 30 mg daily.

The UC application, which was submitted to the FDA in September of last year, is backed up by efficacy and safety data from three Phase III trials, including the U-ACHIEVE and U-ACCOMPLISH induction studies, as well as the U-ACHIEVE maintenance trial.

The results showed that, when compared to placebo, significantly more patients treated with Rinvoq achieved clinical remission at weeks 8 and 52.

Furthermore, the trials achieved all of the ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement.

The safety profile was consistent with that seen in rheumatoid arthritis and atopic dermatitis patients using Rinvoq.

Rinvoq to the rescue

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 US$20.7 billion last year, Rinvoq and Skyrizi generated US$1.65 billion and US$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 US$8 billion to US$7.5 billion.

Because of recent FDA label restrictions on JAK inhibitors, the outlook is around US$500 million lower than previous projections.

A post-marketing study of Pfizer’s Xeljanz linked the treatment to increased heart disease and cancer risks over TNF blockers in a group of older rheumatoid arthritis patients with underlying cardiovascular risk factors, prompting the safety scrutiny for JAK inhibitors.

Despite the risks associated with Xeljanz in that study, the FDA investigated the matter as a classwide issue.

Rinvoq, as well as Pfizer’s subsequent JAK inhibitor Cibinqo, Eli Lilly’s Olumiant, and Incyte’s Opzelura cream, now carry boxed warnings about major cardiovascular events, blood clots, cancer, and death associated with JAK inhibitors.

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