AbbVie Submits Supplemental Applications for Rinvoq


AbbVie is seeking approval in the United States and Europe for Rinvoq to treat patients with Crohn’s disease.

AbbVie has submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for Rinvoq (upadacitinib) to treat adult patients with moderate-to-severe active Crohn’s disease.

The applications are supported by data from three phase 3 clinical trials, including two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE). Across all three studies, significantly more patients treated with Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response. Additionally, more patients receiving Rinvoq 45 mg once daily at week 12 in the induction studies or 15 mg and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission compared with placebo.

No new safety risks observed in the three studies.

In May 2022, AbbVie released results from the U-ENDURE study in which patients from U-EXCEED and U-EXCEL who responded to 12 weeks of Rinvoq 45 mg oral induction treatment were re-randomized to receive Rinvoq 15 mg or Rinvoq 30 mg, or placebo. Clinical remission was defined by the Crohn's Disease Activity Index (CDAI). At week 52, 37% of patients who received 15 mg and 48% of patients who received 30 achieved remission compared with 15% who received placebo. And 28% and 40% of patients who received Rinvoq 15 mg and 30 mg, respectively, achieved endoscopic response compared with 7% of patients who received placebo.

The results of the two induction studies were released previously. Both studies had the same endpoint: clinical remission as measured by CDAI at 12 weeks after induction with Rinvoq 45 mg. U-EXCEED results were released in December 2021, and U-EXCEL results were released in February 2022. The U-EXCEL study confirmed results of the previous study showing improved clinical and endoscopic outcomes of Rinvoq 45 mg.

Earlier this year, the FDA approved the JAK inhibitor for several indications, including moderate-to-serve ulcerative colitis in March 2022 and ankylosing spondylitis, an inflammatory disease that can cause vertebrae to fuse and can lead to a hunched posture, in April 2022, as well as atopic dermatitis in January 2022. Rinvoq is also approved to treat patients with rheumatoid arthritis and psoriatic arthritis.

Related: FDA Requires New Boxed Warning on Xeljanz, other JAK Inhibitors

Rinvoq is also being studied in several immune-mediated inflammatory diseases. Phase 3 trials of atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.

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