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Details:
Tremfya (guselkumab) is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23. It is being evaluated for the treatment of adults with moderately to severely active ulcerative colitis.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2024
Details:
Tremfya (guselkumab) is a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. It is under phase 3 trials for the treatment of moderate to severe scalp psoriasis.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2024
Details:
Tremfya (guselkumab) is a selective IL-23 p19 inhibitor antibody, which is being evaluated for the treatment of moderately to severely active ulcerative colitis.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2023
Details:
Tremfya (guselkumab) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor for the treatment of adult patients living with moderate to severe plaque psoriasis.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2023
Details:
TREMFYA (guselkumab) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor for the treatment of adult patients living with active Psoriatic Arthritis.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
Details:
Tremfya (guselkumab) is a human monoclonal IgG1 lamda antibody that selectively binds to and inhibits its interaction with IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2023
Details:
Tremfya (guselkumab) is a human monoclonal IgG1 lamda antibody that selectively binds to and inhibits its interaction with IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2023
Details:
TREMFYA is the first fully human selective interleukin (IL)-23 inhibitor therapy approved in the U.S. for adults with active PsA and adults with moderate to severe plaque psoriasis (PsO).
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2022
Details:
TREMFYA (guselkumab) is a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2022
Details:
TREMFYA® (guselkumab) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) at 38 weeks.
Lead Product(s): Guselkumab,Golimumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2022
Details:
GUIDE week 28 data demonstrate psoriasis patients treated with Tremfya (guselkumab) ≤2 years after disease onset (versus >2 years) are more likely to achieve super-respondera status (complete skin clearanceb at week 20 through week 28).
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2022
Details:
Data from Phase 3 studies demonstrated patients treated with TREMFYA® (guselkumab) achieved consistent, long-term efficacy through two years across the domains of active psoriatic arthritis (PsA) irrespective of baseline characteristics.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
New data show proportions of patients treated with TREMFYA (guselkumab) who achieved clinical-biomarker response ranged from 47.5-66.7 percent across dose groups in the Phase 2 GALAXI 1 study.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
The results from these studies show that TREMFYA (guselkumab) is differentiated from risankizumab by the capacity of TREMFYA to bind via its native Fc region to CD64, which is expressed on IL-23-producing cells.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Post hoc analysis shows TREMFYA, is first approved fully human mAB, selectively binds to p19 subunit of IL-23 and inhibits its interaction with IL-23 receptor, responders reported clinically significant improvements across measures of social and sexual function and fatigue.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Details:
TREMFYA (guselkumab), first human monoclonal antibody, has a well-established safety and efficacy profile across a broad patient population of adults with moderate to severe PsO and active psoriatic arthritis in gMG patients.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy guselkumab and golimumab, achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12.
Lead Product(s): Guselkumab,Golimumab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2022
Details:
New long-term data show proportions of patients achieving clinical remission ranged from 57.4-73 percent across three TREMFYA dose groups in the Phase 2 GALAXI 1 study.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2022
Details:
Data from the Phase 2b QUASAR Induction Study 1 showed approximately 60 percent of patients achieved the primary endpoint of clinical response, and approximately 30 percent of patients showed endoscopic improvement with TREMFYA treatment compared with placebo.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2022
Details:
TREMFYA ranked highest among 23 active PsA treatment regimens on skin clearance (PASI 90 response) and showed positive joint efficacy (ACR20), including inhibition of structural damage (vdH-S).
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2022
Details:
Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active CD and moderately to severely active ulcerative colitis are ongoing and enrolling participants
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Data from DISCOVER-2 showed that TREMFYA dosing every eight weeks resolved enthesitis and dactylitis through week 100 in 70 percent and 83 percent of biologic-naïve PsA patients, respectively.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
TREMFYA (Guselkumab) is the first and only selective interleukin (IL)-23 inhibitor therapy approved for moderate to severe plaque psoriasis (PsO) and active PsA.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more difficult to treat.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2021
Details:
Royalty Pharma will have the rights to receive MorphoSys' royalties on net sales of Tremfya(R), 80% of future royalties and 100% of future milestone payments on otilimab, 60% of future royalties on gantenerumab, and 3% on future net sales of Constellation's clinical assets.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $2,025.0 million Upfront Cash: $1,425.0 million
Deal Type: Partnership June 02, 2021
Details:
TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis through five years, a and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
Skin clearance rates were maintained at five years with 55.5 percent of patients achieving an Investigator’s Global Assessment score of 0 and 53 percent achieving Psoriasis Area Severity Index 100 response in VOYAGE.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2021
Details:
Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
Details:
TREMFYA improved fatigue during the placebo-controlled periods of both studies at week 24, and through one year of active treatment. In both studies, TREMFYA had positive effect on fatigue, in addition to other clinical outcomes, including ACR20 response.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
Sixteen out of Thirty-five abstracts focus on TREMFYA® (guselkumab) in adults with active PsA, including 52-week safety and efficacy data, spinal disease-related endpoints, as well as analyses that highlight patient-reported outcome measures including fatigue.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Data from VOYAGE 1 open-label, long-term extension study show sustained efficacy response rates at week 252 and no new safety signals. First study of an IL-23 inhibitor treatment to demonstrate safety and efficacy throughout a nearly five-year period of use.
Lead Product(s): Guselkumab
Therapeutic Area: Dermatology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
At 12 weeks, TREMFYA induced significantly greater improvements compared to placebo across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications.1 TREMFYA is not currently approved for the treatment of CD in the U.S.
Lead Product(s): Guselkumab
Therapeutic Area: Gastroenterology Product Name: Tremfya
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
TREMFYA® is the first and only biologic approved for the treatment of both active PsA and moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine involved in normal inflammatory and immune responses.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
In two Phase 3 clinical trials, TREMFYA significantly improved signs and symptoms in joints, skin and soft tissue in adults with active psoriatic arthritis.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Tremfya
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2020
Details:
Findings from the DISCOVER-1 and DISCOVER-2 studies presented at the 2020 European League Against Rheumatism E-Congress. These are the first one-year Phase 3 results evaluating p19 subunit-specific IL-23 inhibition in active psoriatic arthritis.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
DISCOVER-1 and DISCOVER-2, totaling 1120 patients, are the first Phase 3 psoriatic arthritis studies evaluating this mechanism of action.
Lead Product(s): Guselkumab
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2020
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