AbbVie Inc. — Humira FDA Review (BLA125057, SUPPL 393, 2015)
AbbVie Inc. · 2015 · FDA Review (openFDA) · company profile →
Report summary
This FDA approval package details the supplemental Biologics License Application for AbbVie's Humira (adalimumab) for treating moderate to severe hidradenitis suppurativa (HS). Two pivotal Phase 3 trials (M11-313 and M11-810) demonstrated Humira's superiority over placebo in achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. The recommended dosing is 160 mg initially, 80 mg on Day 15, then 40 mg weekly. The safety profile, consistent with other Humira indications, showed no new signals, though a postmarketing requirement for immunogenicity study in HS patients was issued. Warnings include serious infections, malignancies, and hypersensitivity. Efficacy was also confirmed across various other conditions like rheumatoid arthritis, psoriasis, and Crohn's disease. The document also covers pharmacokinetics, immunogenicity, packaging, storage, and patient counseling.
Key findings — cited to the page
| Neutrophils CTCAE Grade ≥2 | 0.8 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Hemoglobin CTCAE Grade ≥3 | 0.8 % | Studies M10-467; M11-313; M11-810 and M12-555 (All Adalimumab Analysis Set) · p.187 |
| Hemoglobin CTCAE Grade ≥3 | 2 subjects | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| WBC count CTCAE Grade ≥2 | 0.3 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Neutrophils CTCAE Grade ≥3 | 0.6 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Hemoglobin CTCAE Grade ≥2 | 3.9 % | Studies M10-467; M11-313; M11-810 and M12-555 (All Adalimumab Analysis Set) · p.187 |
| Hemoglobin CTCAE Grade ≥3 | 1 subject | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Hemoglobin CTCAE Grade ≥3 | 0.3 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Hemoglobin CTCAE Grade ≥3 | 0.6 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Hemoglobin CTCAE Grade ≥2 | 1.7 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| Lymphocytes CTCAE Grade ≥2 | 0.6 % | Studies M10-467; M11-313 and M11-810 (Placebo-Controlled Analysis Set) · p.186 |
| WBC count CTCAE Grade ≥2 | 0.3 % | Studies M10-467; M11-313; M11-810 and M12-555 (All Adalimumab Analysis Set) · p.187 |
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 →