UCB INC — Cimzia FDA Review (NDA/BLA 125160, 2021)
UCB INC · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the May 24, 2018, approval of UCB Inc.'s CIMZIA (certolizumab pegol) for moderate-to-severe plaque psoriasis, adding to existing indications. The review, based on a July 2017 BLA submission, confirmed efficacy and safety through Phase 2 and 3 trials (PS0002, PS0003, PS0005), demonstrating significant clinical response rates (e.g., PASI 75/90) compared to placebo. The report outlines preparation, administration, and critical safety information, including warnings for serious infections (tuberculosis), malignancies, heart failure, and hypersensitivity. Adverse events, immunogenicity (antibody development impacting efficacy), and postmarketing data are discussed. Dosing recommendations consider body weight and the impact of anti-drug antibodies, which can reduce drug exposure and efficacy, particularly with the 200 mg dose in heavier patients. Safety findings from postmarket experience and clinical trials revealed no new concerns, with minimal placental transfer and breast milk levels noted.
Key findings — cited to the page
| Reading ease score for 8th grade reading level | 60 % | · p.219 |
| IGA 0 or 1 with ≥2 grade improvement (%) | 14 % | · p.83 |
| IGA 0 or 1 with ≥2 grade improvement (%) | 31 % | · p.83 |
| Indication | Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy | CIMZIA · p.1 |
| Indication | Treatment of adults with active ankylosing spondylitis | CIMZIA · p.1 |
| Indication | Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy | CIMZIA · p.1 |
| Indication | Treatment of adult patients with active psoriatic arthritis | CIMZIA · p.1 |
| New indication approval | treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy | CIMZIA · p.4 |
| Pediatric study waiver reason (prevalence of psoriasis in 0 to less than 6 years age group) | 0.3 % | · p.5 |
| Pediatric study waiver reason (proportion of children with severe condition in need of systemic treatment) | 4 % | · p.5 |
| Pediatric study waiver reason (final prevalence of condition in 0 to less than 6 years age group) | 1 per 10,000 | · p.5 |
| sBLA submit and received date | July 24, 2017 | CIMZIA · p.4 |
Source: UCB 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 →