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Weekly Top News – IBD – May 20, 2019

etrasimod (APD334) / Arena
ELEVATE UC OLE: An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis(clinicaltrials.gov) – May 15, 2019 – P3; N=702; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Tremfya (guselkumab) / J&J
Tremfya: Regulatory submissions in US/EU for Crohn’s disease and ulcerative colitis between 2019-2023(J&J) – May 16, 2019 – Pharmaceutical Business Review: Regulatory submissions in US/EU for personalized dosing psoriasis between 2019-2023  
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Entyvio (vedolizumab) / Takeda
Entyvio: Regulatory approval in Japan for Crohn’s disease in H1 FY2019 (Takeda) – May 15, 2019 – FY 2018 Results  
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JNJ-64304500 / J&J
JNJ-64304500: Regulatory submissions in US/EU for Crohn’s disease between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi: Regulatory submissions in US/EU for pediatric ulcerative colitis between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104: FDA meeting related to P3 trial design and path to approval in Crohn’s disease in mid-2019(RedHill) – May 16, 2019 – Corporate Presentation  
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PTG-200 / Protagonist Therapeutics, J&J
PTG-200 launch estimate: 2027 (BMO) – May 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67255938; Page no: 8; REPORT TITLE: “Protagonist Therapeutics Inc – Catalyst-rich pipeline highlighted during investor meetings”; AUTHOR: Farmer, George, et al; DATE: 05/06/2019

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

Cyltezo (adalimumab biosimilar) / Boehringer Ingelheim
BI 695501 Versus Humira in Patients With Active Crohn’s Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity (clinicaltrials.gov) – May 15, 2019 – P3; N=147; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Completed

 

Entyvio (vedolizumab) / Takeda
New exploratory data from VARSITY, first head-to-head ulcerative colitis biologic study which demonstrated superiority of vedolizumab to adalimumab in clinical remission at week 52, presented at 2019 Digestive Disease Week (Businesswire) – May 19, 2019 – P3b, N=770; VARSITY (NCT02497469); Sponsor: Takeda; “New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab. These results were announced in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week…”

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