Weekly Top News – IBD – December 9, 2019

December 9, 2019
Inflammatory Bowel Disease

Avsola (infliximab-axxq) / AmgenFDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab) (Amgen Press Release) - Dec 6, 2019 - "Amgen...announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)...AVSOLA, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data."Humira (adalimumab) / Eisai, AbbVieCONTROL: A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab (clinicaltrials.gov) - Dec 3, 2019 - P4; N=238; Not yet recruiting; Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesRemicade (infliximab) / Mitsubishi Tanabe, J&J; Humira (adalimumab) / Eisai, AbbVieTetra Therapeutics announces presentation of data from retrospective population-based study of 56 million patients at the 12th Clinical Trials on Alzheimer’s Disease Meeting (CTAD) (Businesswire) - Dec 4, 2019 - "Tetra Therapeutics...today announced a poster presentation at the 12th Clinical Trials on Alzheimer’s Disease Meeting (CTAD) being held in San Diego, from December 4 – 7....The poster, titled 'Tumor Necrosis Factor (TNF) Blocking Agents Reduce Risk for Alzheimer’s Disease in Patients with Rheumatoid Arthritis and Psoriasis,' highlights data from a retrospective population-based study of 56 million patients in which inflammatory disease in the body is shown to increase risk for Alzheimer’s disease and that risk can be reduced in these patients by treatment with a TNF blocking drug."etrolizumab (RG7413) / RocheA Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2) (clinicaltrials.gov) - Dec 4, 2019 - P3; N=350; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting --> Active, not recruitingozanimod (RPC1063) / BMSOzanimod clinical trial estimate: Primary completion of P3 YELLOWSTONE trial (NCT03440372) for moderate to severe Crohn’s disease in February 2020 and final completion of trial in April 2022 (Morgan Stanley) - Dec 4, 2019 - A subscription to Thomson ONE is required to gain full access to report 68388355; Page no: 22; REPORT TITLE: "Bristol-Myers Squibb: Enhanced cancer leadership, but high patent exposure; Resuming at EW"; AUTHOR: Risinger, David, et al; DATE: 11/22/2019ozanimod (RPC1063) / BMSOzanimod sales projection: $530M in 2023 (Morgan Stanley) - Dec 4, 2019 - A subscription to Thomson ONE is required to gain full access to report 68388355; Page no: 19; REPORT TITLE: "Bristol-Myers Squibb: Enhanced cancer leadership, but high patent exposure; Resuming at EW"; AUTHOR: Risinger, David, et al; DATE: 11/22/2019Alofisel (darvadstrocel) / TakedaAlofisel WW sales projection: Consensus of $252M in 2024 (Bell Potter) - Dec 5, 2019 - A subscription to Thomson ONE is required to gain full access to report 68226796; Page no: 6; REPORT TITLE: "Mesoblast Ltd- MSB: 1QFY20 - Another record quarter for Temcell"; AUTHOR: Jain, Tanushree, et al; DATE: 10/31/2019Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimA Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Dec 6, 2019 - P3; N=940; Recruiting; Sponsor: AbbVie; Trial completion date: Oct 2020 --> Mar 2021; Trial primary completion date: Oct 2020 --> Mar 2021Tremfya (guselkumab) / J&JTremfya sales projection: >$2.5B peak (Trefis) - Dec 7, 2019 - A subscription to Thomson ONE is required to gain full access to report 68403255; Page no: 3; REPORT TITLE: "Johnson & Johnson- Trefis report: Johnson & Johnson - $161 Trefis price estimate”; AUTHOR: Research Department, et al; DATE: 11/26/2019GiFD: Screening of Fabry Disease in Patients With GI Symptoms (clinicaltrials.gov) - Dec 4, 2019 - P; N=200; Recruiting; Sponsor: General University Hospital, Prague