Pfizer Reports FDA Acceptance For Review Of SNDA For Oral Oelja

Pfizer Inc.

announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ^® (tofacitinib citrate) 5 mg and 10 mg tablets, a Janus kinase (JAK) inhibitor, the first in a new class of oral medicines being investigated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in October 2015 for the sNDA. The submission to the FDA is based on data from the Phase 3 Oral treatment Psoriasis Trials (OPT) Program, a global, multi-study, comprehensive clinical development program that consisted of five studies (including an ongoing long-term extension study), designed to evaluate oral XELJANZ 5 mg and 10 mg twice daily in patients with moderate to severe chronic plaque psoriasis. With more than 3,600 adult psoriasis patients enrolled across 36 countries, the OPT program has yielded one of the largest databases for a potential psoriasis indication at the time of registration. XELJANZ is a small molecule that targets the JAK pathway, a signaling pathway inside the cells, thought to play a role in chronic inflammatory responses. "This regulatory milestone demonstrates our commitment to the research of chronic inflammatory diseases with the goal of developing therapies, such as XELJANZ, that can help address unmet medical needs for patients," said Steve Romano, MD, SVP and Head, Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business. "We continue to play a leadership role in the evaluation of JAK inhibition across chronic inflammatory diseases, such as psoriasis." XELJANZ is approved in 37 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA). In the United States, XELJANZ 5 mg tablets are approved for the treatment of adults with moderate to severe RA who have had an inadequate response or intolerance to methotrexate (MTX). The benefit:risk profile of XELJANZ in RA has been characterized through the study of 6,192 RA patients representing 16,800 patient years of exposure in the global clinical development program for XELJANZ in moderate to severe RA.