Gilead Sciences Inc. and partner Galapagos NV said only a higher dose of their experimental drug filgotinib showed greater effectiveness than placebo in a pivotal study testing it in ulcerative colitis patients.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, after an inadequate response or intolerance to TNF blockers.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Pfizer Inc. announced that the supplemental New Drug Application for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis, has been accepted for filing by the U.S. Food and Drug Administration.
