OCTAVE global program

June 1, 2018June 1, 2018

FDA Approves Pfizer’s Xeljanz, an Oral Twice Daily Treatment for Adults with Moderate to Severe Ulcerative Colitis

News

The U.S. Food and Drug Administration (FDA) has approved the oral therapy Xeljanz (tofacitinib), by Pfizer, to treat adults with moderately to severely active ulcerative colitis (UC), the company announced. The treatment regimen calls ... Read more

July 14, 2017August 29, 2017

FDA Considering Pfizer’s Rheumatoid Arthritis Therapy Xeljanz for Ulcerative Colitis, Too

News, Ulcerative colitis

U.S. regulators are considering extending their approval of Pfizer’s rheumatoid arthritis therapy Xeljanz to ulcerative colitis as well. That possibility surfaced when the Food and Drug Administration accepted Pfizer’s supplemental New Drug Application for Xeljanz ... Read more

August 1, 2016August 1, 2016

Promising Phase 3 Trial Results for Ulcerative Colitis Therapy Xeljanz Announced by Pfizer

News

Pfizer has just announced top-line results from OCTAVE Sustain, the third Phase 3 study investigating Xeljanz (tofacitinib citrate) in patients with moderate-to-severe active ulcerative colitis (UC). The OCTAVE Clinical Development ... Read more

September 22, 2015September 22, 2015

Pfizer Reports Favorable Results on Oral Tofacitinib for Ulcerative Colitis

News

Pfizer recently released the top-line results from two Phase III induction studies of twice-daily tofacitinib (10 mg tablets) for ulcerative colitis, within the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) global ... Read more