MedPath

Abrocitinib

Generic Name
Abrocitinib
Brand Names
Cibinqo
Drug Type
Small Molecule
Chemical Formula
C14H21N5O2S
CAS Number
1622902-68-4
Unique Ingredient Identifier
73SM5SF3OR

Overview

Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)–signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells. Patients with moderate-to-severe atopic dermatitis report reduced quality of life and often face limited treatment options. JAK inhibitors recently attracted more attention as potential treatments for inflammatory disorders, as JAK inhibition is associated with rapid and sustained anti-inflammatory efects. Abrocitinib was approved by the European Commission on December 10, 2021, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. On January 14, 2022, the FDA approved abrocitinib for the treatment of refractory, moderate-to-severe AD in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Health Canada also approved the use of abrocitinib in pediatric patients 12 years and older.

Background

Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)–signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells. Patients with moderate-to-severe atopic dermatitis report reduced quality of life and often face limited treatment options. JAK inhibitors recently attracted more attention as potential treatments for inflammatory disorders, as JAK inhibition is associated with rapid and sustained anti-inflammatory efects. Abrocitinib was approved by the European Commission on December 10, 2021, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. On January 14, 2022, the FDA approved abrocitinib for the treatment of refractory, moderate-to-severe AD in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Health Canada also approved the use of abrocitinib in pediatric patients 12 years and older.

Indication

Abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. In the US, it is indicated to treat refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Abrocitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

Associated Conditions

  • Severe Atopic Dermatitis
  • Moderate Atopic dermatitis
  • Moderate, refractory Atopic dermatitis
  • Refractory, severe Atopic Dermatitis

FDA Approved Products

Cibinqo
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/02/13
NDC:0069-0335
Cibinqo
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/02/13
NDC:0069-0235
CIBINQO
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/12/19
NDC:63539-236
CIBINQO
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/12/19
NDC:63539-436
Cibinqo
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/02/13
NDC:0069-0435

Singapore Approved Products

CIBINQO Film-Coated Tablet 200 mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:200.00 mg
Online:Yes
Approved: 2022/01/05
Approval:SIN16414P
CIBINQO Film-Coated Tablet 100 mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:100.00 mg
Online:Yes
Approved: 2022/01/05
Approval:SIN16413P
CIBINQO Film-Coated Tablet 50 mg
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:50.00 mg
Online:Yes
Approved: 2022/01/05
Approval:SIN16412P

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