Cibinqo(abrocitinib)
Immunology· 2559 cited findings· 3 source documents
Company: Pfizer Inc. →
What the regulatory reviews say
Cibinqo (abrocitinib) is a drug reviewed under NDA 213871. The proposed doses are 100 mg or 200 mg. The FDA review document, dated October 12, 2018, includes efficacy and safety data from clinical trials.
Efficacy findings from Phase 3 monotherapy clinical trials indicate that the IGA 0 or 1 responder rate ranged from 23.7% to 42.8%, compared to a placebo IGA 0 or 1 responder rate of 7.9% to 9.1%. The EASI-75 responder rate ranged from 39.7% to 62.7%, compared to a placebo EASI-75 responder rate of 10.4% to 11.8%. One study reported a proportion of subjects achieving IGA of Clear or Almost Clear and ≥2 Points Improvement from Baseline at Week 12 for abrocitinib 100 mg as 27.8%.
The monotherapy safety pool included 778 subjects, with 314 subjects in the 100 mg QD group and 309 subjects in the 200 mg QD group, and 155 subjects in the placebo group. The median age of subjects in this pool was 30 years-old, with 15.9% adolescents. The nadir of thrombocytopenia was observed at 4-weeks. The total number of subjects in all placebo-controlled studies safety pool was 1540, with 8.1% adolescents.
Key figures — cited to the source page
| IGA 0 or 1 responder rate (abrocitinib) | 42.8 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| IGA 0 or 1 responder rate (placebo) | 7.9 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| EASI-75 responder rate (abrocitinib) | 62.7 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| EASI-75 responder rate (placebo) | 11.8 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| Proportion of subjects achieving IGA of Clear or Almost Clear and ≥2 Points Improvement from Baseline at Week 12 (Study B7451006) for abrocitinib 100 mg | 27.8 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.67 |
| Number of subjects in 12-week monotherapy safety pool | 778 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| Median age of subjects in monotherapy safety pool | 30 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24 |
| NDA Number | 213871 | Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.3 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.