Pfizer Reports FDA Acceptance For Review Of SNDA For Oral Oelja

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and DrugAdministration (FDA) has accepted for review the supplemental New DrugApplication (sNDA) for XELJANZ^® (tofacitinib citrate) 5 mg and 10 mg tablets,a Janus kinase (JAK) inhibitor, the first in a new class of oral medicinesbeing investigated for the treatment of adult patients with moderate to severechronic plaque psoriasis who are candidates for systemic therapy orphototherapy. The FDA has provided an anticipated Prescription Drug User FeeAct (PDUFA) action date in October 2015 for the sNDA.The submission to the FDA is based on data from the Phase 3 Oral treatmentPsoriasis Trials (OPT) Program, a global, multi-study, comprehensive clinicaldevelopment program that consisted of five studies (including an ongoinglong-term extension study), designed to evaluate oral XELJANZ 5 mg and 10 mgtwice daily in patients with moderate to severe chronic plaque psoriasis. Withmore than 3,600 adult psoriasis patients enrolled across 36 countries, the OPTprogram has yielded one of the largest databases for a potential psoriasisindication at the time of registration.XELJANZ is a small molecule that targets the JAK pathway, a signaling pathwayinside the cells, thought to play a role in chronic inflammatory responses."This regulatory milestone demonstrates our commitment to the research ofchronic inflammatory diseases with the goal of developing therapies, such asXELJANZ, that can help address unmet medical needs for patients," said SteveRomano, MD, SVP and Head, Global Medicines Development for the Pfizer GlobalInnovative Pharmaceutical business. "We continue to play a leadership role inthe evaluation of JAK inhibition across chronic inflammatory diseases, such aspsoriasis."XELJANZ is approved in 37 countries around the world for the treatment ofmoderate to severe rheumatoid arthritis (RA). In the United States, XELJANZ 5mg tablets are approved for the treatment of adults with moderate to severe RAwho have had an inadequate response or intolerance to methotrexate (MTX). Thebenefit:risk profile of XELJANZ in RA has been characterized through the studyof 6,192 RA patients representing 16,800 patient years of exposure in theglobal clinical development program for XELJANZ in moderate to severe RA.