Weekly Top News – IBD – July 22, 2019

Stelara (ustekinumab) / J&J
Stelara: Regulatory approval in US for ulcerative colitis in 2019 (J&J) – Jul 16, 2019 – Key 2019 Events  
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mirikizumab (LY3074828) / Eli Lilly
Mirikizumab clinical trial estimate: First data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2021(Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 318; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Stelara (ustekinumab) / J&J
Stelara regulatory estimate: Approval for ulcerative colitis in H2 2019 (Wells Fargo) – Jul 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 67590167; Page no: 6; REPORT TITLE: “Johnson & Johnson – JNJ: 2Q19 preview & US pharma tracker”; AUTHOR: Biegelsen, Lawrence, et al; DATE: 07/07/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi clinical trial estimate: Primary completion of P3 trial (NCT03104413) for Crohn’s disease in June 2020 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 67; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Entyvio SC (vedolizumab SC) / Takeda
Investigational subcutaneous formulation of vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn’s disease(Businesswire) – Jul 22, 2019 – P3, N=644; VISIBLE 2 (NCT02611817); Sponsor: Takeda; “In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.”

 

upadacitinib (ABT-494) / AbbVie
Upadacitinib clinical trial estimate: Primary completion of P3 SELECT-GCA trial (NCT03725202) for giant cell arteritis in March 2022 (Cowen & Co) – Jul 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 55; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

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