Abrocitinib FDA Approved for AD

Abrocitinib (Cibunqo; Pfizer), a once-daily, Janus kinase 1 (JAK1) inhibitor, has been approved by the FDA for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.¹

The approved recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose. Also, a 50 mg dose was approved to treat moderate-to-severe AD in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19, according to the press release. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.

“The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options,” said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington DC.“Today’s approval of CIBINQO will provide an important new oral option that could help those who have yet to find relief. In multiple large-scale clinical trials, CIBINQO demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population.”

The approval was based on the results of 5 clinical trials from a large-scale clinical trial program of more than 1,600 patients which assessed the safety and efficacy of the treatment in phase 3 trials. Across the trials, abrocitinib demonstrated a consistent safety profile and improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after 2 weeks, for some people living with AD vs placebo. Also, another 2 monotherapy trials found that a higher proportion of subjects treated with abrocitinib achieved improvement in itching at week 12 compared to placebo.

The most common adverse events (AEs), which were reported in more than 5% of patients treated with abrocitinib are nasopharyngitis (12.4% at the 100 mg dose, 8.7% at the 200 mg dose, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

“The FDA’s approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled,” said Mike Gladstone, global president of Pfizer inflammation & immunology, New York, New York. “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.”

“Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It’s a chronic condition that can both significantly disrupt patients’ daily lives and negatively impact their emotional well-being,” said Julie Block, president and CEO, National Eczema Association, San Francisco, California. “We appreciate Pfizer’s commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis.”

Reference:

1. Breaking news: FDA approves Cibinqo (Abrocitinib). National Eczema Association. Published January 14, 2022. Accessed January 17, 2022. https://nationaleczema.org/cibinqo-approval/