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Weekly Top News – Breast Cancer – May 27, 2019

May 27, 2019

etrasimod (APD334) / Arena
Etrasimod: “Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histologic improvement and remission, and mucosal healing”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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etrasimod (APD334) / Arena
Etrasimod: “Patients who received etrasimod 2 mg exhibited significant decreases in both fecal calprotectin and C-reactive protein versus placebo”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019

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brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrials.gov) – May 23, 2019 – P3; N=1000; Not yet recruiting; Sponsor: Allergan

 

Entyvio (vedolizumab) / Takeda
Entyvio (vedolizumab) approved in Japan for the treatment of patients with moderately to severely active Crohn’s disease (Takeda Press Release) – May 22, 2019 – “Takeda…announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio…for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan.”

 

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

 

mirikizumab (LY3074828) / Eli Lilly
Lilly’s mirikizumab met primary endpoint and key secondary endpoints in phase 2 study, including reductions of gastrointestinal lesions (PRNewswire) – May 21, 2019 – P2, N=180; SERENITY (NCT02891226); Sponsor: Eli Lilly; “Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing….We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.”

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P3; N=372; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

 

mirikizumab (LY3074828) / Eli Lilly
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P2; N=240; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
EU regulators slap safety restriction on Pfizer’s Xeljanz (pharmaphorum) – May 20, 2019 – “European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.”

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