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Abrocitinib FDA Approval Status

FDA Approved: No
Generic name: abrocitinib
Company: Pfizer Inc.
Treatment for: Atopic Dermatitis

Abrocitinib is an oral, small molecule, Janus kinase (JAK) 1 inhibitor in development for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

Development Timeline for abrocitinib

DateArticle
Apr  7, 2021Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
Mar 24, 2021Results 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, 2021Results 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, 2020Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens
Oct 27, 2020FDA 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, 2020Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis
Jun  3, 2020Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology
Mar 18, 2020Pfizer 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, 2019Pfizer 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, 2019Pfizer 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, 2019Pfizer 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

Further information

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