Policy & Regulation
US FDA Approves Pfizer's Cibinqo for Adults with Moderate-to-Severe Atopic Dermatitis
19 January 2022 - - The United States Food and Drug Administration approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable, US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) said.

Cibinqo is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose.

Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19.

For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.

The FDA approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients.

The safety and efficacy of Cibinqo was evaluated in three randomized, placebo-controlled, Phase 3 trials.

Additionally, safety was evaluated through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial.

Across the trials, Cibinqo demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo.

In addition, a higher proportion of subjects treated with Cibinqo in two monotherapy trials achieved improvement in itching at week 12 compared to placebo.

The most common adverse events reported in ≥5% of patients with Cibinqo included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with Cibinqo 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

The full prescribing information for Cibinqo can be found here. Cibinqo will be made available in the coming weeks.

Five clinical trials in the Cibinqo JAK1 Atopic Dermatitis Efficacy and Safety global development program were included in the New Drug Application to support the FDA approval.

The safety and efficacy of Cibinqo was evaluated in three Phase 3, randomized, placebo-controlled clinical trials.

The trials evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment, Eczema Area and Severity Index, and Peak Pruritus Numerical Ratings Scale (PP-NRS).

Cibinqo is an oral small molecule that selectively inhibits Janus kinase 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

In addition to receiving regulatory approval in the US, CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.

Atopic Dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Most people know AD is a skin condition.

But many don't realize it can be caused in part by an abnormal immune response beneath the skin. This dysregulated immune response is thought to contribute to inflammation within the skin and the signs of AD on the surface.

Lesions of AD are characterized by erythema (red/pink or discolored skin patches, depending on normal skin color), itching, lichenification (thick/leathery skin), induration (hardening)/papulation (formulation of papules), and oozing/crusting.

AD is one of the most common inflammatory skin diseases, affecting approximately 5-10% of adults in the US.

Approximately 1 in 3 adults with AD have moderate-to-severe disease.