Beijing News (Reporter Wang Kala) The latest drug approval certificate delivery information released by the National Medical Products Administration shows that Pfizer's highly selective JAK1 inhibitor, the innovative oral small molecule targeted drug Abrocitinib Tablets (trade name: Cibinqo), has been approved for expanded age indication, for the treatment of moderate to severe atopic dermatitis (AD) in adolescents aged 12 years and above and adults.


Atopic dermatitis, known as the "top disease" among skin conditions, ranks first in disease burden among non-fatal illnesses and is characterized by chronic, recurrent, and inflammatory features. In adolescent patients with atopic dermatitis, clinical manifestations often include chronic eczema-like lesions and unbearable itching. The stigma associated with exposed skin lesions significantly impacts the quality of life and mental health of these young patients. About 46% of adolescent patients with atopic dermatitis have had their studies affected during acute flare-ups, and over 50% report reduced self-confidence, social anxiety, and even symptoms of depression.


Statistics show that the prevalence of atopic dermatitis among adolescents aged 12 to 17 worldwide is approximately 5.8%, with about one-third being moderate to severe cases. These patients face a higher risk of comorbid atopic diseases and a greater disease burden. Adolescent patients urgently need more innovative treatment options with good efficacy and safety to address the challenges posed by the condition.


Abrocitinib Tablets Block Multiple Inflammatory Cytokine Signaling Pathways of Atopic Dermatitis, Inhibit JAK1-Mediated Transmission of Various Cytokines Related to the Pathogenesis of Atopic Dermatitis on Sensory Neurons, and Are Expected to Meet Different Clinical Treatment Needs, Helping to Further Improve Treatment Outcomes for Patients with Moderate to Severe Atopic Dermatitis. In the China Subgroup Analysis of the Adolescent Patient Registration Study (JADE TEEN), Abrocitinib Tablets Showed Positive Results.


Abrocitinib Tablets Achieve Global Synchronous R&D and Registration, with China Successfully Participating in Multiple International Multicenter Clinical Trials. In April 2021, Abrocitinib Tablets were granted priority review and approval status by the National Medical Products Administration (NMPA). In April 2022, Abrocitinib Tablets were approved for the treatment of moderate to severe atopic dermatitis in adults and were included in the National Reimbursement Drug List (NRDL) nine months after their market launch.


In 2018, the U.S. Food and Drug Administration (FDA) granted abrocitinib tablets a Breakthrough Therapy designation for the treatment of moderate-to-severe atopic dermatitis. In 2020, abrocitinib tablets were awarded the "Promising Innovative Medicine" title by the UK Medicines and Healthcare products Regulatory Agency (MHRA). To date, abrocitinib tablets have been approved for use in adolescents aged ≥12 years and adults with moderate-to-severe atopic dermatitis in multiple countries and regions, including the UK, Japan, and the United States.


Proofread by Zhai Yongjun