ABBVIE — Rinvoq FDA Review (NDA/BLA 211675, 2024)
AbbVie Inc. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Rinvoq (upadacitinib) extended-release tablets for adults and pediatric patients 12 and older with refractory, moderate-to-severe atopic dermatitis. This approval followed a multi-disciplinary review of efficacy and safety data from clinical trials, demonstrating significant improvements in disease severity and pruritus. Safety information includes warnings for major adverse cardiovascular events (MACE), thrombosis, and malignancies, consistent with the JAK inhibitor class. Postmarketing studies are required, including a pediatric assessment and long-term observational studies to monitor safety risks. The recommended dosage is 15 mg daily, with a higher dose (30 mg) for inadequate response, but 15 mg only for patients 65 and older due to increased risks. Animal studies showed reproductive toxicity, necessitating contraception for women of reproductive potential.
Key findings — cited to the page
| Grade 4 neutropenia (%) | 0 % | · p.183 |
| Grade 3 neutropenia (long-term, adolescent) (%) | 2.4 % | · p.185 |
| Grade 3 neutropenia (%) | 1.3 % | · p.183 |
| Grade 3 neutropenia (adolescent) (%) | 2.6 % | · p.183 |
| Grade 3 neutropenia (long-term) (%) | 1.5 % | · p.185 |
| Grade 3 neutropenia (long-term, adolescent) (%) | 1.8 % | · p.185 |
| Grade 3 neutropenia (%) | 0 % | · p.183 |
| Grade 3 neutropenia (%) | 0.4 % | · p.183 |
| Grade 3 neutropenia (adolescent) (%) | 0 % | · p.183 |
| Grade 3 neutropenia (adolescent) (%) | 0.9 % | · p.183 |
| Grade 3 neutropenia (long-term) (%) | 0.8 % | · p.185 |
| Grade 4 neutropenia (long-term) (%) | 0 % | · p.185 |
Source: AbbVie Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →