The latest move follows the receipt of European Commission (EC) approval for the drug in December last year.
Cibinqo, the oral small molecule drug, selectively hinders Janus kinase (JAK) 1 to modulate multiple cytokines which are involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
It is approved for adult AD patients whose disease is not under control with other medicines including biologics and for those who cannot take other treatments.
The US FDA recommended the 100mg and 200mg doses of the oral small molecule drug to treat adult AD patients, with the 200mg dose for patients who are not responding to the 100mg dose.
In addition, the regulator approved a 50mg Cibinqo dose for the treatment of moderate-to-severe AD patients specifically with kidney failure, patients being treated with cytochrome P450 (CYP) 2C19 inhibitors or patients known or suspected to be poor CYP2C19 metabolisers.
The regulatory approval was based on the data obtained from five clinical trials, including three Phase III trials; a placebo-controlled, randomised, dose-ranging trial; and an ongoing long-term open-label extension trial.
These five clinical trials were conducted on more than 1,600 patients.
The drug showed consistent safety profile and improvements in disease extension, severity, skin clearance, compared to placebo, in these clinical studies.
It also showed rapid improvement in itch relief after two weeks of treatment in the trials.
Pfizer Inflammation & Immunology global president Mike Gladstone said: “The FDA’s approval offers hope to the millions of patients across the US who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled.
“CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials.”
The company stated that Cibinqo showed improvement in itching in most of the patients after 12 weeks of treatment, in two monotherapy trials that compared the drug with placebo.