ABBVIE INC — Humira FDA Review (NDA/BLA 125057, 2026)
AbbVie Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Humira's (adalimumab) approval on June 30, 2016, for numerous indications including rheumatoid arthritis, Crohn's disease, psoriasis, and uveitis. It outlines dosage, administration, and significant safety warnings, particularly regarding serious infections, malignancies, and liver enzyme elevations. Efficacy data from various clinical trials consistently demonstrate Humira's superiority over placebo across adult and pediatric populations. The report also covers specific populations, immunogenicity, and detailed instructions for patient self-administration. A supplemental BLA for non-infectious uveitis was approved based on Phase 3 studies (M10-877, M10-880) showing prolonged time to treatment failure, with a safety profile consistent with known risks. Pregnancy and lactation safety data are also included.
Key findings — cited to the page
| Pediatric Crohn's Disease induction dose (≥ 40 kg) | 160 mg on Day 1; 80 mg on Day 15 | HUMIRA · p.15 |
| Pediatric Crohn's Disease maintenance dose (≥ 40 kg) | 40 mg every other week | HUMIRA · p.15 |
| Adult Crohn's Disease maintenance dose | 40 mg every other week | HUMIRA · p.15 |
| Pediatric Crohn's Disease maintenance dose (17 kg to < 40 kg) | 20 mg every other week | HUMIRA · p.15 |
| Approval Date | June 30, 2016 | HUMIRA (adalimumab) · Global · p.1 |
| Indication | Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. | HUMIRA (adalimumab) · p.1 |
| Indication | Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. | HUMIRA (adalimumab) · p.1 |
| 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.1 |
| Indication | Reducing signs and symptoms in adult patients with active AS. | HUMIRA (adalimumab) · p.1 |
| Pediatric Crohn's Disease induction dose (17 kg to < 40 kg) | 80 mg on Day 1; 40 mg on Day 15 | HUMIRA · p.15 |
| Indication | Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. | HUMIRA (adalimumab) · p.1 |
| Adult Ulcerative Colitis maintenance dose | 40 mg every other week | HUMIRA · p.15 |
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 →