Cibinqo FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 28, 2023.
FDA Approved: Yes (First approved January 14, 2022)
Brand name: Cibinqo
Generic name: abrocitinib
Dosage form: Tablets
Company: Pfizer Inc.
Treatment for: Atopic Dermatitis
Cibinqo (abrocitinib) is a Janus kinase (JAK) 1 inhibitor for the treatment of moderate-to-severe atopic dermatitis.
- Cibinqo is indicated for the treatment of adults and pediatric patients 12 years of age with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
- Cibinqo works to treat atopic dermatitis by selectively inhibiting Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
- Cibinqo is administered orally once daily.
- The FDA approval of Cibinqo was based on results of five clinical trials from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program of more than 1,600 patients. The safety and efficacy of Cibinqo was evaluated in three Phase 3, randomized, placebo-controlled clinical trials. Across the trials Cibinqo demonstrated a consistent safety profile and improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks compared to placebo.
- The Cibinqo product label carries a boxed warning for the increased risk of serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis.
- Common adverse reactions include nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis, impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.
Development timeline for Cibinqo
| Date | Article |
|---|
| Feb 10, 2023 | Approval FDA Approves Pfizer's Supplemental New Drug Application for Cibinqo (abrocitinib) to Include Adolescents with Moderate-to-Severe Atopic Dermatitis |
| Jan 14, 2022 | Approval FDA Approves Cibinqo (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis |
| Aug 30, 2021 | Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis |
| Apr 7, 2021 | Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis |
| Mar 24, 2021 | Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine |
| Mar 24, 2021 | Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine |
| Nov 11, 2020 | Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens |
| Oct 27, 2020 | FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis |
| Jun 10, 2020 | Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis |
| Jun 3, 2020 | Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology |
| Mar 18, 2020 | Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch |
| Oct 12, 2019 | Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis |
| Sep 27, 2019 | Pfizer Announces Positive Top-Line Results from Second Pivotal Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib, in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis |
| May 15, 2019 | Pfizer Announces Positive Top-Line Results from Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib (PF-04965842), in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis |
| Feb 14, 2018 | Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis |
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