AbbVie Adds Crohn’s Disease to Rinvoq’s Growing List of Indications
BIOMARKER
1. The FDA approves AbbVie's Rinvoq (upadacitinib) for the treatment of moderate to severely active Crohn's disease in adult patients.
2. This marks Rinvoq's seventh overall approval and the first oral drug indicated for Crohn's disease.
3. Three trials, U-EXCEED, U-EXCEL, and U-ENDURE, support Rinvoq's efficacy in achieving endoscopic response and clinical remission in Crohn's disease patients.
4. Rinvoq demonstrated endoscopic response in 35% to 46% of patients in U-EXCEED and U-EXCEL compared to 3% to 13% in the placebo group.
5. In U-ENDURE, 28% and 41% of patients treated with Rinvoq showed endoscopic response at week 52.
6. Rinvoq led to clinical remission rates of 36% to 46% in the induction studies and 18% to 23% in the maintenance study.
7. Data suggest that Rinvoq provides early and long-term symptom relief and improves intestinal damage due to inflammation in Crohn's disease.
8. CD is the seventh indication for Rinvoq, following approvals for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.
9. AbbVie's Rinvoq push comes amid declining sales of Humira, with increasing biosimilar pressure impacting its revenue.
10. Amgen's Amjevita became the first Humira biosimilar in the U.S., with more expected to enter the market in 2023.