Pfizer Gains FDA and EMA Acceptance for Abrocitinib

October 29, 2020
Pharmaceutical Technology Editors

Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.

Pfizer has announced that the US Food and Drug Administration (FDA) has accepted for filing and granted priority review designation for a new drug application and the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for abrocitinib.

According to an Oct. 27, 2020 press release, both regulatory agencies are expected to make decisions in 2021. Abrocitinib is an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor to treat atopic dermatitis (AD) in patients who are 12 years old and older. The filings with both FDA and EMA were based on Phase III clinical trial results, in which abrocitinib demonstrated statistically superior improvements in skin clearance, disease extent, and severity, as well as improvements in itch, when compared with placebo.

“AD is a serious, unpredictable, and often debilitating condition that can have a significant impact on the daily lives of patients and their families,” said Michael Corbo, PhD, chief development officer, Inflammation & Immunology, Pfizer Global Product Development, in the press release. “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 [European Union], where, if approved, it may provide an effective and convenient new option.”

“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,” said Jonathan Silverberg, MD, PhD, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. “Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of AD, including rapid reduction of itch, across multiple clinical trials. If abrocitinib is approved, it could make a meaningful difference in real-world clinical practice.”

Source: Pfizer