FDA Approves Abrocitinib for Adults With Moderate to Severe Atopic Dermatitis

The FDA recently announced the approval of abrocitinib (Cibinqo), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults with refractory, moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products or when use of those therapies is inadvisable.

Developed by Pfizer, the approval of abrocitinib’s New Drug Application (NDA) is based on results of 5 clinical trials in the Cibinqo JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. In each trial, more than 40% of patients had prior exposure to a systemic therapy.

The safety and efficacy of the drug, measured via the Investigator Global Assessment (IGA; severity), Eczema Area and Severity Index (EASI; disease extent), and Peak Pruritus Numerical Ratings Scale (PP-NRS; severity), were examined in 3 phase 3, randomized, placebo-controlled clinical trials across 12 weeks:

• JADE MONO-1 and JADE MONO-2, which asssessed abrocitinib 100 mg and 200 mg monotherapy doses in 778 patients 12 years and older with moderate to severe AD
• JADE COMPARE examined abrocitinib 100 mg and 200 mg doses in 837 adult patients with moderate to severe AD in combination with topical medicated therapy
  

Compared with placebo, significantly improved IGA response rates were shown in patients given 100 mg and 200 mg doses of abrocitinib in the JADE MONO-1 (8% vs 24% and 44%, respectively), JADE MONO-2 (9% vs 28% and 38%, respectively), and JADE COMPARE (14% vs 36% and 47%, respectively) studies at week 12.

Significant improvements vs placebo were also shown for the EASI-75 (≥75% improvement in lesion extent and severity) metric for patients with moderate to severe AD given 100 mg and 200 mg doses of abrocitinib in the JADE MONO-1 (12% vs 40% and 62%, respectively), JADE MONO-2 (10% vs 44% and 61%, respectively), and JADE COMPARE (27% vs 58% and 68%, respectively) studies at 12 weeks.

Common adverse events were reported in 5% or less of participants treated with abrocitinib, which included nasopharyngitis, nausea, and headache.

“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.

The Institute for Clinical and Economic Review, which recently reviewed and supported the use of JAK inhibitors in the treatment of AD, estimated abrocitinib’s Health Benefit Price Benchmark to range from $30,600 to $41,800 for each intervention.

“The FDA’s approval offers hope to the millions of patients across the United States 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 inflammation and immunology at Pfizer.