▎WuXi AppTec Content Team Report

Today (March 1), the latest announcement on the official website of China's National Medical Products Administration (NMPA) stated,PfizerOral JAK1 Inhibitor Abrocitinib TabletsNew IndicationsThe marketing application has been approved.According toPriority Review Public Notice by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), this drug has been approved in this review.Indications: For patients who have had an inadequate response to other systemic treatments (such as hormones or biologics) or are unsuitable for the aforementioned treatments.Adolescent patients aged 12 years and above with refractory, moderate to severe atopic dermatitisPreviously, the product had been approved in China for the treatment of refractory, moderate to severe atopic dermatitis.Adult Patients。

Screenshot source:NMPA Official Website

Atopic DermatitisInflammation is aA chronic skin disease characterized by skin inflammation and skin barrier defects, which is marked by severe itching and recurrent skin lesions. It can also be accompanied by chronic conditions such as asthma, allergic rhinitis, and insomnia symptoms, significantly reducing the patient's quality of life.Atopic DermatitisInflammationIt is also a common chronic recurrent childhood skin condition, affecting approximately 10% of adults and around 20% of children globally. Many patients with moderate to severe conditions have poor disease control and require additional treatment options to alleviate symptoms.

Abrocitinib（abrocitinib）It is a once-daily oral, highly selective JAK1 inhibitor. JAK1 inhibition is thought to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukins IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). In April 2022, abrocitinib was approved in China.Approved for Marketing, used to treat adult patients with refractory, moderate to severe atopic dermatitis. This approval of abrocitinib is for the indication ofAdolescents aged 12 years and abovePatients with moderate to severe atopic dermatitis.

According to publicly available information from Pfizer, AbrocitinibA new indication for treating atopic dermatitis in adolescents aged 12 to 18 has been approved by the U.S. FDA in February 2023. The efficacy of this product has been validated in five randomized, placebo-controlled clinical trials and one long-term extension study.These studies involved more than 1,600 patients.In all trials to date, compared with placebo,Abrocitinib Demonstrates Consistent Safety and Significant Improvement in Skin Clearance, Disease Extent and Severity, and Rapid Relief of Itch in Some Adolescents and Adults with Atopic Dermatitis Within Two Weeks。

Among them, the JADE TEEN studyEvaluated abrocitinib in285 adolescent patients (aged 12-18 years) with moderate to severe atopic dermatitisEfficacy and safety in adolescents. Data showed that after 12 weeks of treatment with abrocitinib,More effective than placebo treatment，100mg GroupInvestigator Global Assessment Score (IGA)0 or 1缓解率为39%, 46% in the 200mg group, and 24% in the placebo group;Three groups of patientsEczema Area and Severity Index improved by ≥75% (EASI-75) The ratioRespectively64%, 71%, and 41%. The safety profile was consistent with the results from pivotal trials and the adult population.

[1] Drug Approval Certificate Delivery Information Released on March 1, 2024. Retrieved Mar 1, 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html

[2]FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib). Retrieved Feb 10, 2023, from https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-supplemental-new-drug-application