New drugs for special dermatitis! Pfizer's next-generation oral JAK1 inhibitor abrocitinib enters the review in the US and Europe!

Oct 30, 2020 // -- Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has accepted abrocitinib (100 mg, 200 mg) of new drugs Application (NDA) and granted priority review of the drug, a once-a-day oral JAK1 inhibitor used to treat patients aged ≥12 with moderate to severe endexual dermatitis (AD).
FDA is expected to make a review decision in April 2021.
addition, the European Medicines Agency (EMA) has accepted applications for marketing authorization (MAA) from abrocitinib in the same patient group and is expected to make a review decision in the second half of 2021.
abrocitinib is an oral small molecule that selectively inhibits Janus kinase 1 (JAK1).
inhibition of JAK1 is thought to regulate a variety of cytokines in the pathophysiological process of atopic dermatitis (AD), including lecytokine (IL)-4, IL-13, IL-31, and interferon γ.
the United States, the FDA in February 2018 granted abrocitinib a breakthrough drug qualification (BTD) for moderate to severe AD treatment.
(AD) is a serious, unpredictable, often debilitating skin disease that can have a significant impact on the daily lives of patients and their families.
of patients with moderate to severe conditions are poorly controlled and require additional treatment options to alleviate the symptoms that are most important to them.
in several clinical trials, abrocitinib has been highly effective in alleviating AD symptoms and signs, including rapidly reducing itching.
if approved, abrocitinib would make a meaningful difference in real-world clinical practice.
regulatory filing for abrocitinib molecular structure (Photo: medchemexpress.cn) is based on the results of a strong Phase 3 clinical trial project.
in this project, abrocitinib showed statistical superiority in skin loss removal, disease range and severity compared to placebo, and itching symptoms improved rapidly (as early as week 2).
abrocitinib also showed consistent safety in the trial and was generally well-to-do.
submission includes the following findings from the abrocitinib JADE global development project: -JADE MONO-1 and JADE MONO-2: These two studies assessed the efficacy and safety of abrocitinib monotherapy and placebo in 2 doses (100mg and 200mg, once a day).
- JADE COMPARE: The study evaluated the efficacy and safety of abrocitinib and placebo in patients receiving background local treatment in 2 doses (100mg and 200mg, once daily).
the study also included a positive control group that received epitheliotic injection biotherapy dupilumab and was compared with a placebo.
, Pfizer announced positive results for the fourth clinical trial of the JADE TEEN study in the JADE Global Development Program.
additional data from other JADE studies will be released in the coming months.
Origin: FDA Grants Review and EMA Accepts Regulatory Submission for Pfizer's Abrocitinib, an Oral Once-Daily JAK1 Resor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis