Drugs in the Pipeline, News
Tofacitinib Ext-Rel Monotherapy Effective for Moderate to Severe RA After Methotrexate Withdrawal
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Your search for tofacitinib returned 16 results
Drugs in the Pipeline
Upadacitinib Gets FDA’s Priority Review for Treatment of Moderate to Severe RA
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).
Drugs in the Pipeline
Xeljanz Under FDA Review for Psoriatic Arthritis
An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.
Drugs in the Pipeline
Xeljanz Demonstrates Efficacy in Third Phase 3 Ulcerative Colitis Study
Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).
Drugs in the Pipeline
Positive Results for Oral Tofacitinib in Ulcerative Colitis Presented
Pfizer announced detailed results from the first 2 pivotal Phase 3 trials of the OCTAVE program evaluating oral tofacitinib 10mg twice daily in inducing remission in adults with moderately to severely active ulcerative colitis (UC). Findings were orally presented at the 11th Congress of ECCO Scientific Session.
Drugs in the Pipeline
Complete Response Letter Issued for Xeljanz on New Indication
The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.
Drugs in the Pipeline
Tofacitinib Demonstrates Efficacy for Potential UC Indication
Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).
Drugs in the Pipeline
FDA to Review New Xeljanz Formulation for Rheumatoid Arthritis
Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.
Drugs in the Pipeline
New Data Shows Tofacitinib Effective for Plaque Psoriasis
Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Drugs in the Pipeline
Xeljanz sNDA Accepted for Review for Plaque Psoriasis
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.
