J&J submits supplemental BLA to U.S. FDA seeking approval of TREMFYA
HORSHAM, Pa., Jan. 22, 2024 /PRNewswire/ -- Johnson & Johnson today announced that TREMFYA® (guselkumab) demonstrated rapid and significant clearance in moderate to severe scalp psoriasis (PsO) and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks. Topline data from Cohort B in the Phase 3b VISIBLE study were presented today at the Maui Derm Hawaii 2024 conference.
SPRING HOUSE, Pa., Nov. 8, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new data from the CorEvitas Psoriatic Arthritis (PsA) and Spondyloarthritis Registry that showed a substantial proportion of people living with treatment-resistant active PsA and using TREMFYA® (guselkumab) in real-world settings reported meaningful improvements in pain, physical function and fatigue through six months.1 Additionally, across the DISCOVER-1, DISCOVER-2 and COSMOS clinical trials, treatment with TREMFYA was associated with higher rates of clinically meaningful improvements in a composite assessment of patient-reported pain, fatigue, physical function, skin problems and PsA-related depression than placebo in the first assessment of the PsA 5-Thermometer Scale Domains (PsA-5T-Ds).2
Johnson & Johnson’s first-ever clinical study in psoriasis with patients of color found its treatment Tremfya works similarly across diverse populations, but that’s not the only result it’s amplifying.
SPRING HOUSE, Pa., Oct. 23, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, today announced new data from the QUASAR Phase 3 Induction Study demonstrating the efficacy and safety profile of TREMFYA® (guselkumab), a selective IL-23 p19 inhibitor, in patients with moderately to severely active ulcerative colitis (UC) through 24 weeks.1 High rates of clinical responsea were observed at Weeks 12 or 24, with no new safety signals observed compared to the safety profile of TREMFYA in its approved indications.1 Symptomatic responseb and improvements in patient-reported outcomes of rectal bleeding and absolute stool number were observed as early as one week after a single intravenous (IV) induction dose, with symptomatic response evident in more than two-thirds of patients at Week 12.2 These data are among Janssen's 20 oral and poster presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Vancouver, Canada, October 20-25, 2023.
HORSHAM, Pa., Oct. 20, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial, the first prospective, large-scale, randomized-controlled trial dedicated to patients across all skin tones with moderate to severe plaque psoriasis and scalp psoriasis to objectively measure clearance and other treatment outcomes with TREMFYA® (guselkumab). In the study, TREMFYA demonstrated significant skin clearance, rapid scalp psoriasis clearance and improvement in health-related quality of life outcomes. In this previously understudied population, no new safety signals were reported through Week 16.1,2,3 These data will be presented today at the 2023 Fall Clinical Dermatology Conference in Las Vegas, Nevada.
SPRING HOUSE, Pa., Oct. 16, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, today announced new data from the long-term extension (LTE) of the GALAXI Phase 2 study demonstrating the durable clinical and endoscopic efficacy of TREMFYA® (guselkumab), a selective IL-23 p19 inhibitor, in patients with moderate-to-severe Crohn's disease (CD), now through a total of three years.1 Rates of clinical remission and endoscopic response were maintained through three years. The safety profile of TREMFYA was consistent with that of its currently approved indications.1 These data are among Janssen's 17 oral and poster presentations at the United European Gastroenterology (UEGW) Week 2023 taking place in Copenhagen, Denmark, October 14-17, 2023.
SPRING HOUSE, Pa., Oct. 9, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced that 30 company-sponsored presentations will be featured at the European Academy of Dermatology and Venereology (EADV) Congress taking place in Berlin, Germany from October 11-14, 2023. Janssen will present new data on the underlying science of the treatment of psoriasis (PsO), including results from the Phase 3b GUIDE trial highlighting early intervention with TREMFYA® (guselkumab) (Abstract #FC08.5)1 and systemic pharmacodynamica response data for JNJ-2113 from the Phase 2 FRONTIER 1 trial (Abstract #FC08.2).2
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J), has recently released new data on Tremfya (guselkumab), a monoclonal antibody that targets IL-23 in adults with moderate-to-severe plaque psoriasis (PsO).
Janssen has released new safety and efficacy data from a Phase III trial investigating Tremyfa (guselkumab) in adults with moderately to severely active ulcerative colitis (UC).