U.S. FDA Approves Pfizer’s CIBINQO (abrocitinib), a Once-Daily Oral JAK1 Inhibitor, for Adults with Refractory Moderate-to-Severe Atopic Dermatitis

News on January 15, 2022 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has approved Cibinqo (abrocitinib, 100mg, 200mg): This medication is aOnce-daily oral JAK1 inhibitor for the treatment of adult patients with refractory moderate to severe atopic dermatitis (AD)The drug is specifically indicated for: adult patients with refractory moderate to severe AD who have had an inadequate response to other systemic treatments (including biologics) or are not suitable for these therapies. In the European Union, Cibinqo was approved in December 2021 for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy.

In terms of dosage, the recommended doses for Cibinqo are 100mg and 200mg. For patients who do not respond to the 100mg dose, it is recommended to use the 200mg dose. Additionally, the 50mg dose has been approved for treating moderate to severe AD adult patients with moderate renal impairment (kidney failure), those receiving treatment with cytochrome P450 (CYP) 2C19 inhibitors, or those with known or suspected poor CYP2C19 metabolism. For patients with severe renal impairment, if there is no response to the 50mg dose taken once daily, a 100mg dose taken once daily can also be administered.

Cibinqo is a new generation of oral JAK1 inhibitor developed by Pfizer, in large-scaleClinical TrialThe safety and efficacy of the project have been proven. Previously, Cibinqo has also been approved in the UK and Japan for the treatment of moderate to severe AD adolescents and adult patients aged 12 years and above who are suitable for systemic therapy and have an inadequate response to existing therapies. In the UK and Japan, the approved doses of Cibinqo are 100mg and 200mg.

United StatesFDAThe approval of Cibinqo was based on the results of five clinical studies from a large-scale clinical program involving over 1,600 patients. The safety and efficacy of Cibinqo were evaluated in three randomized, placebo-controlled Phase 3 trials. Additionally, safety was assessed through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial. In these trials,Cibinqo demonstrated consistent safety and significantly improved skin lesion clearance, disease extent, and severity compared to placebo. Notably, Cibinqo rapidly alleviated itching as early as 2 weeks into treatment. Additionally, in two monotherapy studies...Clinical TrialIn China, a higher proportion of patients receiving Cibinqo experienced improvement in itching at week 12 compared to those receiving placebo.In terms of safety, the most commonly reported adverse events (occurring in ≥5% of patients) were nasopharyngitis (12.4% in the Cibinqo 100mg group, 8.7% in the 200mg group, and 7.9% in the placebo group), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

Abrocitinib Molecular Structure (Source: medchemexpress.cn)

Atopic Dermatitis (AD) is a chronic skin disease characterized by skin inflammation and skin barrier defects, with features including erythema, pruritus, induration/papule formation, and exudation/crusting. This condition is a severe, unpredictable, and often debilitating skin disorder that significantly impacts the daily lives of patients and their families. Many individuals with moderate to severe disease have inadequate control of their symptoms and require additional treatment options to alleviate the most important symptoms for them.

In September 2021, Cibinqo was approved in the UK and Japan for the treatment of moderate to severe atopic dermatitis (AD) in adolescents and adults aged 12 years and older who are candidates for systemic therapy and have had an inadequate response to existing therapies. In December 2021, Cibinqo was approved in the European Union, and currently, the marketing application for abrocitinib has been submitted to multiple countries and regions worldwide for review. In the United States,FDAIn February 2018, abrocitinib was granted Breakthrough Therapy Designation (BTD) for the treatment of moderate to severe AD. (Bioon.com)

Source of Original Text:U.S. FDA Approves Pfizer’s CIBINQO (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis