Posted by Michael Wonder on 05 Aug 2015
Pfizer Announces FDA acceptance for review of supplemental new drug application for oral Xeljanz (tofacitinib citrate) for adult patients with moderate to severe chronic plaque psoriasis
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.
