AbbVie has been following a dependable playbook as it develops its young immunology blockbuster Rinvoq, a follow-up to its aging Humira.
Relatively early in its life cycle, five years after it hit the market, Humira gained an approval to treat Crohn’s disease. Rinvoq now appears on a similar track as it has reported promising phase 3 data in a Crohn’s disease trial.
Rinvoq, originally approved in 2019 to treat rheumatoid arthritis, has been shown to be effective as a maintenance therapy in the 52-week U-ENDURE study. The results bolster Rinvoq’s previous success versus Crohn’s in the 12-week U-EXCEED and U-EXCEL studies, which AbbVie reported last year.
For the yearlong study, patients who responded well to the 45-mg dose in the induction phase of those earlier trials were re-randomized to receive a 30-mg or 15-mg dose of the drug or placebo. Of those who took the higher dose, 48% achieved clinical remission. That compared with 37% of patients on the lower drug dose and 15% for the placebo group.
As a secondary measure, the trial also used cameras to assess inflammation levels and healing. Those dosed with Rinvoq 30 mg and 15 mg showed more endoscopic response at 40% and 28%, respectively, versus 7% on placebo. They also showed more endoscopic remission at 29% and 19% for the high dose and low dose, respectively, versus 5% on placebo.
A filing with the FDA is due later this year. If successful, Rinvoq would become the first JAK inhibitor endorsed for use against Crohn’s.
Rinvoq generated sales of $1.65 billion last year. It's already approved to treat patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis and ankylosing spondylitis.
Humira’s sales came in at $20.8 billion last year. Its first four approved indications were for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease.
Rinvoq's progression is crucial for AbbVie as Humira is set to face competition from cheaper biosimilars next year.