Pfizer Reports FDA Acceptance For Review Of SNDA For Oral Xelja
Pfizer Inc. (NYSE: PFE) 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
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.
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