October 15, 2021: “
Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The CHMP also adopted a positive opinion recommending an extension to the existing indications for XELJANZ® (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
“The CHMP’s positive recommendation brings us closer to our goal of helping people living with moderate to severe atopic dermatitis in Europe find relief,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We look forward to working with the European Commission and hope to soon provide abrocitinib to people in Europe and eventually to more people worldwide who are living with this debilitating disease, many of whom have limited treatment options today.”
“Atopic dermatitis can be a debilitating condition that impacts the daily lives of millions of people,” said Dr. Diamant Thaci, Comprehensive Center for Inflammation Medicine, University of Luebeck, Germany. “Abrocitinib has shown significant efficacy, including relief from the hallmark chronic itch, rapid improvements in skin clearance, extent and severity of disease versus placebo, and a favorable risk-benefit profile. If approved, abrocitinib may become an important new treatment option for patients living with moderate to severe atopic dermatitis.”
Based on these CHMP recommendations, a decision by the European Commission, which authorizes marketing approval in the European Union, is expected on the abrocitinib and XELJANZ applications later this year. If granted by the European Commission, the centralized marketing authorizations would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.
The recommendation for abrocitinib is based on the results of five Phase 3 studies and a long-term extension study from a robust clinical trial program including more than 3,100 patients.
The recommendation for XELJANZ is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of XELJANZ twice daily versus placebo in 269 adult patients living with active AS.
About Abrocitinib
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).
CIBINQO® (abrocitinib) received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) in September 2021.
About XELJANZ
XELJANZ is approved in the European Union in four indications: adults with moderately to severely active rheumatoid arthritis (RA) after disease modifying antirheumatic drug (DMARD) failure or intolerance, adults with active psoriatic arthritis (PsA) after DMARD failure or intolerance, adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent, and active polyarticular juvenile idiopathic arthritis (JIA) and juvenile PsA in patients two years of age and older who have responded inadequately to previous therapy with DMARDs. Limitations of Use below.
XELJANZ has been studied in more than 50 clinical trials worldwide and prescribed to more than 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012.i,ii.
In June 2021, the Committee for Medicine Products for Human Use of the European Medicines Agency adopted a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC) following its review of XELJANZ in the European Union, which states that in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular (CV) risk factors, and patients with other malignancy risk factors, XELJANZ should only be used if no suitable treatment alternatives are available. The CHMP-endorsed PRAC recommendation is applicable to all EU member states and has been implemented in the XELJANZ summary of product characteristics.
Pfizer is also continuing to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to review the full results and analysis of the ORAL Surveillance data.
Most recently in September 2021, the FDA issued a Drug Safety Communication (DSC) related to XELJANZ®/XELJANZ XR® and two other arthritis medicines in the same drug class, based on its completed review of the ORAL Surveillance trial.
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.
Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.
AD affects up to 10% of adults worldwide.v The prevalence of AD in adults in the European Union is approximately 5-10%.”
