Pfizer Inc. — Cibinqo FDA Review (NDA213871, ORIG 1, 2022)
Pfizer Inc. · 2022 · FDA Review (openFDA) · company profile →
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The FDA review of Pfizer's Cibinqo (abrocitinib) for moderate-to-severe atopic dermatitis (NDA 213871) evaluated its clinical pharmacology, efficacy, and safety. Abrocitinib, a JAK1 inhibitor, demonstrated significant efficacy in improving IGA and EASI-75 scores compared to placebo in Phase 3 trials, with a dose-dependent response. However, safety concerns, particularly with the 200 mg dose, include increased risks of serious infections, malignancies, VTE, and laboratory abnormalities (e.g., thrombocytopenia, lymphopenia). Nonclinical studies also revealed reproductive and developmental toxicities. The drug's pharmacokinetics, pharmacodynamics, and drug-drug interactions were characterized, leading to recommendations for dose adjustments based on renal/hepatic impairment and co-medications. Due to safety concerns, a boxed warning and a limited indication as a third-line therapy are recommended, with the 200 mg dose reserved for patients failing the 100 mg dose.
Key findings — cited to the page
| Probability of Grade 3 or Grade 4 thrombocytopenia | 3 % | · p.122 |
| Probability of nadir in Grade 2 or more severe thrombocytopenia (<75×10^3/μL) for an individual with baseline of 170×10^3/μL on abrocitinib 100 mg QD | 11.6 % | Cibinqo (abrocitinib) · p.68 |
| Probability of Grade 3 and Grade 4 thrombocytopenia for abrocitinib 100 mg QD | 0 % | Cibinqo (abrocitinib) · p.68 |
| Probability of nadir in Grade 2 or more severe thrombocytopenia (<75×10^3/μL) for an individual with baseline of 170×10^3/μL on abrocitinib 200 mg QD | 19.3 % | Cibinqo (abrocitinib) · p.68 |
| Probability of Grade 3 or more severe thrombocytopenia for Asians with increased exposure | <1 % | · p.239 |
| Probability of Grade 3 or more severe thrombocytopenia with a baseline platelet count of 270·1000/μL | 0 % | · p.239 |
| Probability of Grade 3 or more severe thrombocytopenia (<50×10^3/μL) for individuals with lower baseline platelet count (170×10^3/μL) on abrocitinib 100 mg QD | 3 % | Cibinqo (abrocitinib) · p.63 |
| Probability of Grade 3 or more severe thrombocytopenia (<50×10^3/μL) for individuals with lower baseline platelet count (170×10^3/μL) on abrocitinib 200 mg QD | 1.9 % | Cibinqo (abrocitinib) · p.63 |
| Probability of Grade 3 and Grade 4 thrombocytopenia for abrocitinib 200 mg QD | 0 % | Cibinqo (abrocitinib) · p.68 |
| probability of Grade 2 or more severe thrombocytopenia in non-Japanese Asians with 100 mg QD | 0 % | non-Japanese Asians · p.71 |
| probability of Grade 2 or more severe thrombocytopenia in Japanese Asians with 100 mg QD | 0.5 % | Japanese · p.71 |
| Exposure multiple (AUC comparison) for irreversibly decreased femur size, paw malrotation, and limb impairment in juvenile rats | 10 times MRHD | · p.186 |
Source: Pfizer 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 →