Instant Report
FDF

Date: 08-Apr-2021

US FDA Extends Review Period Of Pfizers NDA For Abrocitinib To Treat Moderate To Severe Atopic Dermatitis

Pfizer Inc. announced that the US Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021.

The FDA has also extended the review period for the Supplemental New Drug Applications (sNDAs) for Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) by three months, with a goal date in early Q3 2021.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

Xeljanz (tofacitinib) is approved in the US in four indications: adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure, adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure, and patients 2 years of age or older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Xeljanz has been studied in more than 50 clinical trials worldwide and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last eight years.

As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.