Tag Archives: xeljanz

May, 2018

31 May
Pfizer’s Xeljanz Receives FDA Approval for Treatment of Moderately to Severely Active Ulcerative Colitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately …
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15 December
Pfizer’s Xeljanz and Xeljanz XR Receive FDA Approval for the Treatment of Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response …
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14 December
FDA Extends Action Date for Xeljanz sNDA in Ulcerative Colitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). The …
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16 June
Pfizer Announces Results from Xeljanz ORAL Strategy Study in Patients with Rheumatoid Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today detailed results from ORAL Strategy, a head-to-head, noninferiority Phase 3b/4 study of XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) as monotherapy or in combination with methotrexate (MTX) compared to Humira® plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). …
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3 May
FDA Accepts for Review Pfizer’s sNDA for Xeljanz for Treatment of Patients with Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also …
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17 February
Pfizer Announces Top-Line Results from the Oral Strategy Trial of Xeljanz Compared to Humira

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination …
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7 November
Pfizer Presents Additional Research for Xeljanz in Rheumatologic Diseases

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that 20 abstracts for XELJANZ® (tofacitinib citrate) will be presented at the upcoming 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). Notably, results from the two pivotal Phase 3 OPAL (Oral Psoriatic Arthritis TriaL) studies of tofacitinib – the only Janus kinase (JAK) …
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27 September
Prime Therapeutics Research Finds Nearly Half of Members Discontinue Costly RA Drug After One Year

ST. PAUL, MINN. – Sept. 27, 2016 – Prime Therapeutics LLC (Prime), a pharmacy benefit manager serving over 22 million members nationally, analyzed members’ use of rheumatoid arthritis (RA) drug tofacitinib (Xeljanz®) to find patterns and adherence behaviors. While use of the drug had been low (one member per 100,000 …
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29 July
Pfizer’s Xeljanz Demonstrates Positive Results in its Late-Stage Ulcerative Colitis Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated …
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25 February
FDA Approves Pfizer’s Xeljanz XR for Treatment of Rheumatoid Arthritis

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). XELJANZ XR is the …
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