Applications for Medicine Treating Crohn’s Disease Submitted to EMA and FDA

AbbVie announced on July 27 that applications for their new medication, upadacitinib (RINVOQ®), have been submitted to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). The application’s foundation is top-line findings of three Phase 3 clinical trials testing the treatment for application in adults with moderate to severe Crohn’s Disease.

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RINVOQ’s Effect on Crohn’s Disease

Crohn’s Disease is a type of inflammatory bowel disease that progressively worsens over time and might eventually worsen to the point where those suffering from it require urgent medical care, involving surgery in some cases. The symptoms can involve abdominal pain, diarrhea, weight loss, anemia, and fatigue, with potentially life-threatening complications.

Though the disease is lifelong, RINVOQ works to treat the symptoms caused by Crohn’s Disease. RINVOQ works to inhibit proteins from the Janus kinase (JAK) family, which helps regulate swelling. By inhibiting the protein, RINVOQ works to lessen the overactive immune response caused by Crohn’s Disease.

Applications Based on Positive Phase 3 Data

In total, there were three Phase 3 clinical trials to study the induction and maintenance of the treatment. U-EXCEED and U-EXCEL were induction studies designed to test the efficacy and safety of RINVOQ 45 mg once daily as induction therapy. At the same time, U-ENDURE did much the same, although on RINVOQ 15 mg and 30 mg once daily as maintenance therapy. All the studies were double-blind and placebo-controlled, conducted on adults with moderately to severely active Crohn’s disease.

All three studies achieved top-line results as patients treated with RINVOQ met the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment.

These results are the foundation of AbbVie’s application to both the FDA and EMA.

Neil Gallagher, M.D., Ph.D., vice president, development, and chief medical officer at AbbVie, said in a statement, “Crohn’s disease can be debilitating and have a significant impact on a person’s daily life. Those patients still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition.”

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Max Heirich