The Food and Drug Administration (FDA) has accepted for review the sNDA for Xeljanz (tofacitinib citrate; Pfizer) 5mg and 10mg tablets for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
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Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
Pfizer announced top-line results from two pivotal Phase 3 trials, evaluating the efficacy and safety of Xeljanz (tofacitinib) for the treatment of moderate-to-severe plaque psoriasis.
Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
The FDA has accepted Pfizer’s sNDA for review for an expanded indication for Xeljanz to include inhibition of progression of structural damage in the label. Xeljanz is a first in its class Janus Kinase inhibitor.
Pfizer announced top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib in the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).
Pfizer announced that the FDA has accepted for review its New Drug Application (NDA) for tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The NDA is based on previously completed Phase 3 trials.