Xeljanz sNDA Accepted for Review for Plaque Psoriasis
Pfizer announced that the Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) 5mg and 10mg tablets for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Xeljanz is a Janus kinase (JAK) inhibitor.
The sNDA submission 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. These studies were designed to evaluate oral XELJANZ 5mg and 10mg twice daily in patients with moderate to severe chronic plaque psoriasis.
Xeljanz are already indicated for moderately-to-severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
For more information call (800) 438-1985 or visit Pfizer.com.