Pfizer’s regulatory filing for abrocitinib is based on clinical trial data showing improvement in symptoms, along with a consistent safety profile
Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)
Pfizer has secured the US Food and Drug Administration (FDA) Priority Review for abrocitinib (100mg and 200mg) to treat moderate to severe atopic dermatitis (AD) in patients aged 12 years and above.
Abrocitinib is an oral small molecule, capable of selectively inhibiting Janus kinase (JAK), to modulate multiple cytokines associated with the pathophysiology of atopic dermatitis.
The US regulatory agency has accepted the company’s New Drug Application (NDA) for abrocitinib. FDA is anticipated to announce its decision on the regulatory application in April 2021.
Also, the European Medicines Agency (EMA) has accepted Pfizer’s marketing authorisation application (MAA) for the drug in the same patient population. EMA’s decision is expected in the second half of 2021.
Pfizer inflammation and immunology global product development chief development officer Michael Corbo said: “Atopic dermatitis is a serious, unpredictable, and often debilitating condition that can have a significant impact on the daily lives of patients and their families.
“We are grateful to those who participated in our clinical studies supporting these regulatory filings and proud that the FDA has granted abrocitinib both Breakthrough Therapy and Priority Review designations. We are working diligently with the regulatory authorities to bring abrocitinib to patients in the US and the EU, where, if approved, it may provide an effective and convenient new option.”
Pfizer’s filings for abrocitinib were based on Phase 3 JADE clinical trial programme
Pfizer said that its regulatory filings with FDA and EMA were supported by the results from a large-scale Phase 3 clinical trial programme, dubbed JADE (JAK1 Atopic Dermatitis Efficacy and Safety).
JADE MONO-1 and JADE MONO-2 trials evaluated the efficacy and safety of abrocitinib in 100mg and 200mg once daily doses as monotherapy compared to placebo.
Another study JADE COMPARE has assessed the efficacy and safety of 100mg and 200mg once-daily doses of the drug in patients on background topical therapy, compared to placebo.
In the late-stage trials, abrocitinib showed superior improvements in skin clearance, disease extent, and severity, along with rapid improvements in itch, compared to placebo.
Also, the JAK inhibitor was generally well-tolerated and demonstrated a consistent safety profile across the clinical trials.
George Washington University school of medicine and health sciences department of dermatology professor Jonathan Silverberg said: “Many patients with moderate to severe atopic dermatitis have poorly controlled disease. They need additional treatment options that alleviate the symptoms most important to them.
“Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of atopic dermatitis, including rapid reduction of itch, across multiple clinical trials. If abrocitinib is approved, it could make a meaningful difference in real-world clinical practice.”