The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of August. The chart below provides highlights of key monograph updates made this month (not an inclusive list).
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.
Pfizer announced that the FDA has approved a sNDA to update the current label of Xeljanz (tofacitinib citrate) tablets to include radiographic data from two Phase 3 studies, ORAL Scan and ORAL Start.
Pfizer announced that the FDA has approved the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) to include additional patient-reported outcomes data in the label.
This CME/CEU activity is designed to give clinicians a better understanding of the pharmacology, indications, contraindications, benefits/risk and clinical trials data of a broad spectrum of new agents and those that have been granted a new indication.
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 that the FDA has approved Xeljanz (tofacitinib citrate) tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had inadequate response or intolerance to methotrexate.
This patient information fact sheet provides information on the definition, symptoms, causes, diagnostic tests, treatments and self-help measures for rheumatoid arthritis.