AbbVie Submits Applications to EMA, FDA for Upadacitinib to Treat Crohn Disease


Submissions are based on 3 phase 3 clinical trials showing that the drug achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment.

AbbVie submitted applications for a new indication to the European Medicines Agency and the FDA for upadacitinib (Rinvoq, with a 45-mg starting dose and a 15- and 30-mg maintenance dose) for the treatment of individuals with moderately to severely active Crohn disease (CD).

“Crohn disease can be debilitating and have a significant impact on a person's daily life,” Neil Gallagher, MD, PhD, vice president of development and chief medical officer at AbbVie, said in a statement. “Those patients who are still suffering fuel our continued commitment to innovation in care for patients with [inflammatory bowel disease], and we look forward to potentially introducing a new treatment option for this disruptive condition.”

The applications to the agencies are supported by 3 phase 3 clinical trials, including 2 induction studies, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and 1 maintenance study, U-ENDURE (NCT03345823). Across all studies, investigators found that significantly more individuals treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.

Additionally, investigators saw that they had a clinical remission measured by the Crohn’s Disease Activity Index (CDAI) by patient-reported symptoms of stool frequency/abdominal pain (SF/AP).

Further, more individuals who received upadacitinib 45 mg once daily at week 12 in the induction studies or 15 and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per CDAI and per SF/AP compared with the placebo among individuals taking corticosteroids at baseline.

The safety results across all 3 studies were generally consistent with the known safety profile of upadacitinib with no new safety risks observed. Serious adverse events related to upadacitinib include allergic reactions; an increased risk of death for those aged 50 years and older with at least 1 cardiovascular (CV) risk factor, cancer, and immune system issues; an increased risk of major CV events; blood clots; and serious infection

The 3 phase 3 studies were double-blinded, multicenter, placebo-controlled, and randomized. They were used to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy and upadacitinib 15 and 35 mg once daily as maintenance therapy in adults with moderately to severely active CD.

The topline results from the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022, respectively. The topline results from the U-ENDURE maintenance study were announced in May 2022.

Upadacitinib is a JAK inhibitor that is being studied for serval immune-mediated inflammatory diseases, demonstrating greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. It is used to treat adults with active ankylosing spondylitis, active psoriatic arthritis, moderate to severe rheumatoid arthritis, and moderate to severe ulcerative colitis.

Phase 3 trials of upadacitinib, including for atopic dermatitis, axial spondylarthritis, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and Takayasu arteritis, and ulcerative colitis are ongoing. The use of the drug for CD is not approved, and regulatory authorities have not evaluated its efficacy and safety.


AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn’s disease. New release. AbbVie. July 27, 2022. Accessed August 1, 2022.

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