Pfizer Inc. — Cibinqo EMA EPAR public assessment report (EMEA/H/C/005452, 2021)
Pfizer Inc. · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Pfizer's Cibinqo (abrocitinib) resulted in a positive opinion for marketing authorization for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older. The report details the drug's quality, stability, and non-clinical pharmacology, highlighting its JAK1 selectivity. Pharmacokinetic studies show rapid absorption and extensive metabolism. Non-clinical safety studies revealed immune system effects, bone development issues in rats, and potential carcinogenicity. Clinical trials demonstrated significant efficacy in improving IGA, EASI-75, and pruritus, with the 200mg dose generally showing higher efficacy. Safety concerns include infections (especially herpes zoster), malignancies, cardiovascular events, and hematological changes. Due to bone development concerns in adolescents, the indication was restricted to adults, with ongoing pharmacovigilance planned.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test (Mortality) for abrocitinib | 0.971 mg/L | · p.44 |
| Percentage of abrocitinib becoming irreversibly bound to sediment | 25.1 to 28.4 % | · p.43 |
| NOEC for Daphnia sp. Reproduction Test (Length) for abrocitinib | 0.971 mg/L | · p.44 |
| Probability of Grade ≥ 3 thrombocytopenia | <3 % | · p.68 |
| NOEC for Daphnia sp. Reproduction Test (Reproduction) for abrocitinib | 0.971 mg/L | · p.44 |
| HADS Anxiety, change from baseline | -0.4 | COMPARE · p.102 |
| SCORAD Sleep VAS, change from baseline | -2.1 | MONO-2 · p.102 |
| HADS Depression, change from baseline | -1.8 | MONO-1 · p.102 |
| SCORAD Sleep VAS, change from baseline | -2.9 | MONO-1 · p.102 |
| SCORAD Sleep VAS, change from baseline | -3.7 | MONO-1 · p.102 |
| SCORAD Sleep VAS, change from baseline | -3.0 | MONO-2 · p.102 |
| SCORAD Sleep VAS, change from baseline | -1.6 | MONO-1 · p.102 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →