AbbVie submits applications to EMA and FDA for upadacitinib in the treatment of Crohn’s disease

Submissions are based on 3 Phase 3 clinical trials showing the drug met the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance therapy.

AbbVie has filed New Indication Applications with the European Medicines Agency and the FDA for upadacitinib (Rinvoq, with a starting dose of 45 mg and a maintenance dose of 15 and 30 mg) for the treatment people with moderate to severe active Crohn’s disease (CD).

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

The agency submissions are based on 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, researchers found that significantly more people treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.

Additionally, the researchers found that they had clinical remission as measured by Crohn’s disease activity index (CDAI) based on patient-reported stool frequency/abdominal pain (SF/AP) symptoms. .

Additionally, more people 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 clinical remission without corticosteroids according to CDAI and according to SF/AP compared to placebo in those taking corticosteroids at baseline.

The safety results in the 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 in people aged 50 and over with at least one cardiovascular (CV) risk factor, cancer and immune system problems; an increased risk of major CV events; blood clots; and severe infection

The 3 phase 3 studies were double-blind, 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 moderate to severe active CD.

The main results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022, respectively. The main results of 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, showing greater inhibitory potency for JAK-1 compared to 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 spondylitis, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, Takayasu’s arteritis and ulcerative colitis are ongoing. The drug is not approved for use in CD, and regulatory authorities have not evaluated its efficacy and safety.


AbbVie is submitting regulatory submissions to the FDA and EMA for upadacitinib (Rinvoq) in Crohn’s disease. New version. AbbVie. July 27, 2022. Accessed August 1, 2022. crohns-disease.htm

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