Upadatinib's launch accelerated: Crohn's disease has simultaneously submitted marketing applications in FDA&EMA

On July 27, AbbVie announced that it had submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for upadacitinib (trade name Rinvoq, 45mg [induction dose] and 15mg and 30 mg [maintenance dose]) for a new indication for the treatment of adult patients with moderately to severely active Crohn's disease.

The application, submitted to the FDA and EMA, is supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE).

In all three studies, patients treated with upadacitinib met the co-primary endpoint of clinical remission and endoscopic remission, as measured by Crohn's disease activity index (CDAI) or patient-reported stool frequency/abdominal pain symptoms (SF/AP) ) to evaluate.

In addition, patients who received 45 mg once daily at Week 12 in the induction study or 15 mg and 30 mg once daily at Week 52 in the maintenance study met the secondary endpoint of corticosteroid use at baseline compared to placebo In contrast, clinical remission without corticosteroids was achieved in CDAI and SF/AP.

The safety results of upadacitinib in U-EXCEED, U-EXCEL and U-ENDURE were largely consistent with the known upadacitinib safety profile, with no new safety risks observed.

It is worth mentioning that the European Commission (EC) approved Rinvoq (upadacitinib 45mg [induction dose] and 15mg and 30mg [maintenance dose]) a day earlier (July 26) for the treatment of insufficient response to conventional therapy or biologics Adult patients with moderately to severely active ulcerative colitis with loss of response or intolerance.

Rinvoq has been approved for use in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis and other indications, among which axial spondyloarthritis, giant cell arteritis and Takayasu A phase 3 trial in arteritis is ongoing.