ABBVIE INC — Humira FDA Review (NDA/BLA 125057, 2021)
AbbVie Inc. · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
Humira (adalimumab) received FDA approval for pediatric Crohn's Disease (CD) in 2014, following a supplemental Biologics License Application (sBLA). This report details Humira's efficacy and safety across various inflammatory conditions, including adult and pediatric CD, psoriatic arthritis, and ankylosing spondylitis. Clinical studies, particularly M06-806, demonstrated Humira's effectiveness in achieving clinical remission and response in pediatric CD patients, with a higher-dose regimen showing numerically superior outcomes. Safety concerns include serious infections, malignancies, and other adverse events, consistent with its use in other indications. No new safety signals were identified in pediatric CD. The report also covers pharmacokinetics, immunogenicity, dosing guidelines, packaging, and patient counseling, emphasizing critical safety information and proper administration. The overall risk-benefit assessment supported approval for children aged 6 and older with moderate to severe CD.
Key findings — cited to the page
| Indication | Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. | HUMIRA (adalimumab) · p.9 |
| Indication | Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. | HUMIRA (adalimumab) · p.9 |
| Revised date of Instructions for Use | 9/2014 | · p.84 |
| Dosage and Administration, General Considerations for Administration | 9/2014 | HUMIRA (adalimumab) · p.9 |
| Approval Date | September 23, 2014 | HUMIRA (adalimumab) · p.1 |
| Indication | Reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 4 years of age and older. | HUMIRA (adalimumab) · p.9 |
| Indication | treatment of pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. | HUMIRA (adalimumab) · p.1 |
| Warning | Serious Infections and Malignancy | HUMIRA (adalimumab) · p.9 |
| Indication and Usage, Pediatric Crohn’s Disease | 9/2014 | HUMIRA (adalimumab) · p.9 |
| Dosage and Administration, Pediatric Crohn’s Disease | 9/2014 | HUMIRA (adalimumab) · p.9 |
| PCDAI clinical response (%) | 59.1 % | Study M06-806 · p.216 |
| Indication | Reducing signs and symptoms in adult patients with active AS. | HUMIRA (adalimumab) · p.9 |
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 →