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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – September 28, 2020

September 28, 2020

etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in Q4 2020 (Arena) – Sep 24, 2020 – Jefferies Virtual Next Generation IBD Therapeutics Summit: Top-line data from P3 ELEVATE UC 52 trial for ulcerative colitis in Q4 2021; Top-line data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in Q4 2021 
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Jyseleca (filgotinib) / Gilead
Stock market look: Galapagos on track in Japan and EU [Google Translation] (DeAandeelhouder.nl) – Sep 24, 2020 – “The filing for ulcerative colitis in the United States will depend on the results the Manta study produces in the first half of 2021…The Phase 3 Diversity study of filgotinib with Crohn’s disease is expected to provide data in 2022.”

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of trial for ulcerative colitis in early 2021 (Arena) – Sep 24, 2020 – Jefferies Virtual Next Generation IBD Therapeutics Summit 
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Entyvio (vedolizumab) / Takeda
CHRONOS: A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD) (clinicaltrials.gov) – Sep 25, 2020 – P=N/A; N=60; Completed; Sponsor: Takeda; Active, not recruiting –> Completed; N=150 –> 60

 

ABX464 / Abivax
Abivax Presents First-Half 2020 Financial Results and Operations Update (Yahoo Finance) – Sep 26, 2020 – “77% (180/232) of patients randomized in ABX464 Phase 2b ulcerative colitis study, recruitment expected to be completed by the end of 2020. ABX464 pivotal Phase 2b/3 trial for Crohn’s disease planned with anticipated start of patient recruitment in Q1 2021….”

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Weekly Top News – IBD – September 21, 2020

September 21, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: Final data from P3 BERGAMOT trial (NCT02394028) for moderate-to-severe Crohn’s disease in 2021 (Roche) – Sep 15, 2020 – Roche Pharma Day 2020 
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Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
OCTAVE: Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis (clinicaltrials.gov) – Sep 15, 2020 – P3; N=944; Completed; Sponsor: Pfizer; Active, not recruiting –> Completed

 

ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 307) (clinicaltrials.gov) – Sep 14, 2020 – P3; N=40; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting; N=983 –> 40; Trial completion date: Aug 2022 –> Jun 2021; Trial primary completion date: Aug 2022 –> Jun 2021

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals Announces First Subject Dosed in ELEVATE UC 12 Global Phase 3 Trial Evaluating Etrasimod in Ulcerative Colitis (Arena Press Release) – Sep 16, 2020 – “We are pleased to initiate the ELEVATE UC 12 Phase 3 trial…This is a significant milestone for Arena as the progress confirms that the ELEVATE UC registrational program, including ELEVATE UC 12 and UC 52 trials, remains on track for data by year-end 2021.”

 

ontamalimab (SHP647) / Takeda
FIGARO UC 303: An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Sep 14, 2020 – P3; N=366; Active, not recruiting; Sponsor: Shire; Recruiting –> Active, not recruiting; N=696 –> 366; Trial completion date: Jun 2024 –> Jun 2021; Trial primary completion date: Jun 2024 –> Jun 2021

 

Rinvoq (upadacitinib) / AbbVie
U-Accomplish: A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Sep 14, 2020 – P3; N=523; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

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Weekly Top News – IBD – September 14, 2020

September 14, 2020

etrolizumab (RG7413) / Roche
A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis (clinicaltrialsregister.eu) – Sep 12, 2020 – P3; N=372; Ongoing; Sponsor: F. Hoffmann-La Roche Ltd

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn’s Disease Who Failed Prior Biologic Treatment (clinicaltrials.gov) – Sep 11, 2020 – P3; N=618; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

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Weekly Top News – IBD – September 7, 2020

September 7, 2020

llllllllll TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Sep 3, 2020 – P2/3; N=500; Recruiting; Sponsor: Theravance Biopharma; Not yet recruiting –> Recruiting

 

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Sep 2, 2020 – P3; N=931; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

 

llllllllll Remsima SC (infliximab biosimilar SC) / Celltrion
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Sep 3, 2020 – P3; N=615; Recruiting; Sponsor: Celltrion; Not yet recruiting –> Recruiting; Initiation date: Mar 2020 –> Sep 2020

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Weekly Top News – IBD – August 24, 2020

August 24, 2020

llllllllll ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 306) (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Trial completion date: Aug 2021 –> Aug 2020; Trial primary completion date: Aug 2021 –> Aug 2020

 

llllllllll Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Highmark Forges Outcomes-Based Contract with UCB for Anti-Inflammatory Drug CIMZIA (certolizumab pegol) (PRWeb) – Aug 18, 2020 – “Highmark announced that it has entered an outcomes-based agreement with UCB, Inc. (‘UCB’) for UCB’s medication CIMZIA® (certolizumab pegol)…for adult patients with chronic inflammatory conditions that include Crohn’s disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis….With outcomes-based agreements between a pharmaceutical drug manufacturer and payer, reimbursement for a drug is based in part on its clinical effectiveness for those patients using the drug. If clinical outcomes are not met, the pharmaceutical drug manufacturer typically refunds part of the original purchase to the payer.”

 

llllllllll ontamalimab (SHP647) / Takeda
FIGARO UC 302: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Aug 19, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Trial completion date: Jul 2024 –> Oct 2020; Trial primary completion date: Jul 2024 –> Oct 2020

 

llllllllll ontamalimab (SHP647) / Takeda
FIGARO UC 301: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Aug 19, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Trial completion date: Jul 2024 –> Oct 2020; Trial primary completion date: Jul 2024 –> Oct 2020

 

llllllllll ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 305) (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Trial completion date: Aug 2021 –> Oct 2020; Trial primary completion date: Aug 2021 –> Oct 2020

 

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn’s Disease (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1250; Recruiting; Sponsor: AbbVie; Trial primary completion date: Oct 2025 –> May 2026

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Weekly Top News – IBD – August 17, 2020

August 17, 2020

llllllllll Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib Induction (clinicaltrials.gov) – Aug 10, 2020 – P3; N=76; Not yet recruiting; Sponsor: University of Miami

 

llllllllll etrolizumab (RG7413) / Roche
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) – Aug 9, 2020 – P3; N=397; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed

 

llllllllll etrolizumab (RG7413) / Roche
Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis (GlobeNewswire) – Aug 10, 2020 – “In the HIBISCUS I induction study…etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study…did not meet its primary endpoint. In the HICKORY study…etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study…etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date….Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings….Pivotal phase III study of etrolizumab in Crohn’s disease is ongoing…”

 

llllllllll Jyseleca (filgotinib) / Gilead
MANTA: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (clinicaltrials.gov) – Aug 10, 2020 – P2; N=250; Active, not recruiting; Sponsor: Gilead Sciences; Recruiting –> Active, not recruiting

 

llllllllll Entyvio (vedolizumab) / Takeda
Takeda expects more effective IBD treatment with Kynteles’ expanded reimbursement (Korea Biomedical Review) – Aug 12, 2020 – “Takeda Korea is strengthening its position in the domestic inflammatory bowel disease (IBD) market with Kynteles receiving expanded reimbursement as a first-line treatment, the company said in a news conference Wednesday.”

 

llllllllll Gattex (teduglutide) / Takeda
20 most expensive drugs in the US (Becker’s Hospital Review) – Aug 12, 2020 – “For its list, published Aug. 11, GoodRx excluded drugs that have to be administered by a healthcare provider. The prices reflect list prices for the drug’s most common 30-day prescription. The 20 most expensive drugs based on their monthly list prices: 10. Gattex — $40,450 (Takeda).”

 

llllllllll Zeposia (ozanimod) / BMS
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Aug 11, 2020 – P3; N=535; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2023 –> Sep 2024; Trial primary completion date: Mar 2023 –> Jun 2024

 

llllllllll Zeposia (ozanimod) / BMS
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Aug 11, 2020 – P3; N=600; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2022 –> Jun 2023; Trial primary completion date: Mar 2022 –> Jun 2023

 

llllllllll Zeposia (ozanimod) / BMS
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Aug 11, 2020 – P3; N=1040; Recruiting; Sponsor: Celgene; Trial completion date: Jun 2024 –> Jun 2026; Trial primary completion date: Mar 2024 –> Jun 2026

 

llllllllll Zeposia (ozanimod) / BMS
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Aug 14, 2020 – P3; N=600; Recruiting; Sponsor: Celgene; Trial completion date: Apr 2024 –> Jul 2023; Trial primary completion date: Apr 2024 –> Apr 2023

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Weekly Top News – IBD – August 3, 2020

August 3, 2020

llllllllll brazikumab (AMG 139) / AstraZeneca
Brazikumab: Data from P2b/3 INTREPID trial (NCT03759288) for Crohn’s disease in 2021 or later (AstraZeneca) – Jul 30, 2020 – H1 2020 Results: Data from P3 trial (NCT03961815) for Crohn’s disease in 2021 or later 
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llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Data from P3 KEEPsAKE 1 trial (NCT03675308) for psoriatic arthritis in 2020 (AbbVie) – Aug 1, 2020 – Q2 2020 Results: Data from P3 trial (NCT03105102) for Crohn’s disease in Q4 2020/Q1 2021

 

llllllllll brazikumab (AMG 139) / AstraZeneca
Brazikumab: Data from P2 EXPEDITION trial (NCT03616821) for ulcerative colitis in 2021 or later (AstraZeneca) – Jul 30, 2020 – H1 2020 Results: Data from P2 trial (NCT04277546) for ulcerative colitis in 2021 or later 
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llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Regulatory submissions for Crohn’s disease and psoriatic arthritis in 2021 (AbbVie) – Aug 1, 2020 – Q2 2020 Results

 

llllllllll Rinvoq (upadacitinib) / AbbVie
Rinvoq: Top-line data from P3 trial (NCT03006068) for ulcerative colitis in 2020 (AbbVie) – Aug 1, 2020 – Q2 2020 Results

 

llllllllll Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie Reports Second-Quarter 2020 Financial Results (AbbVie Press Release) – Jul 31, 2020 – “AbbVie…announced financial results for the second quarter ended June 30, 2020….Global Humira net revenues of $4.837 billion decreased 0.7 percent on a reported basis, or 0.2 percent on an operational basis. U.S. Humira net revenues were $3.974 billion, an increase of 4.8 percent. Internationally, Humira net revenues were $863 million, a decrease of 19.9 percent on a reported basis…due to biosimilar competition. Global Skyrizi net revenues were $330 million. Global Rinvoq net revenues were $149 million….Global Botox Therapeutic net revenues were $297 million, a decrease of 22.3 percent on a comparable operational basis, due to the COVID-19 pandemic….Global Ubrelvy net revenues were $22 million.”

 

llllllllll Remsima SC (infliximab biosimilar SC) / Celltrion
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis (Businesswire) – Jul 27, 2020 – “Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….We will accelerate the launch process on a country-by-country basis…Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe.”

 

llllllllll mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 2 trial (NCT03524092) in moderate-to-severe ulcerative colitis in Mar 2021 (Eli Lilly) – Jul 31, 2020 – Q2 2020 Results: Primary completion of P3 LUCENT-ACT trial (NCT04469062) for ulcerative colitis in Mar 2024; Completion of P3 LUCENT-ACT trial for ulcerative colitis in Jun 2024 
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Weekly Top News – IBD – July 20, 2020

July 20, 2020

llllllllll JNJ-64304500 / J&J
JNJ-64304500: NME filing in US for Crohn’s disease between 2020-2023 (J&J) – Jul 16, 2020 – Pipeline Update: Regulatory submission in EU for Crohn’s disease between 2020-2023
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llllllllll mirikizumab (LY3074828) / Eli Lilly
LUCENT-ACT: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (clinicaltrials.gov) – Jul 13, 2020 – P3b; N=1100; Not yet recruiting; Sponsor: Eli Lilly and Company

llllllllll mirikizumab (LY3074828) / Eli Lilly; Cosentyx (secukinumab) / Novartis
Lilly’s Mirikizumab Superior to Cosentyx (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis (Eli Lilly Press Release) – Jul 17, 2020 – P3, N=1,443; OASIS-2 (NCT03535194); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that mirikizumab…met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study….’We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis,’ said Andrew Blauvelt, M.D….Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn’s data in 2022; Lilly will submit data from OASIS-1 and 2 to regulatory authorities around the world.”

llllllllll Tremfya (guselkumab) / J&J
Tremfya: Data from P2/3 GALAXI trial (NCT03466411) for Crohn’s disease in 2020 (J&J) – Jul 16, 2020 – Key 2020 Events
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llllllllll etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jul 17, 2020 – P3; N=330; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

llllllllll mirikizumab (LY3074828) / Eli Lilly
Lily ’Mirikizumab’ approved for Phase 3 clinical trial for Crohn’s disease [Google Translation] (Medical News) – Jul 15, 2020 – “The Ministry of Food and Drug Safety (Chief Lee Eui-kyung) approved a phase 3 clinical trial to evaluate long-term efficacy and stability of ‘Mirikizumab (LY3074828)’ of ‘Korea Lily’ on the 13th….This phase 3 trial will be conducted at Ajou University Hospital, Inje University Haeundae Paik Hospital, Seoul Asan Hospital, Yeungnam University Hospital, and Gangbuk Samsung Hospital.”

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University; Humira (adalimumab) / Eisai, AbbVie; Rinvoq (upadacitinib) / AbbVie
Pharma’s TV ad spending level sets in June, with AbbVie, Sanofi and Regeneron leading the way (Fierce Pharma) – Jul 16, 2020 – “The top 10 TV buyers’ total spending was $141 million, almost the same as the $140 million from June 2019….Sanofi and Regeneron’s type 2 anti-inflammatory med Dupixent at $13.1 million in June TV media buys….1. Humira: Total estimated spending: $44.3 million (up from $32.5 million in May); 3. Xeljanz: Total estimated spending: $12.5 million (up from $11.5 million in May); 9. Rinvoq: Total estimated spending: $9 million (down from $12.9 million in May); 10. Skyrizi: Total estimated spending: $8.8 million (up from $8.7 million in May).” 

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Weekly Top News – IBD – July 13, 2020

July 13, 2020

Entyvio (vedolizumab) / Takeda
Takeda launches Vedolizumab in India for treatment of ulcerative colitis, Crohn’s Disease (Outlookindia.com) – Jul 8, 2020 – “Drug firm Takeda India on Wednesday said it has launched biological drug Vedolizumab under the brand name ‘Kynteles’ used for the treatment of adult patients with moderate-to-severely active ulcerative colitis and Crohn’s Disease, at a price of Rs 71,310 per vial in India….’We continue to optimise our prices from patient access perspective and it is currently priced at Rs 71,310 per vial’. The recommended dose regimen of Kynteles is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter in both UC and CD, he added.”

 

Zeposia (ozanimod) / BMS
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jul 9, 2020 – P3; N=1012; Completed; Sponsor: Celgene; Active, not recruiting –> Completed

 

mirikizumab (LY3074828) / Eli Lilly
VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Jul 7, 2020 – P3; N=778; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting –> Recruiting

 

Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
UCB and Ferring Pharmaceuticals Announce Co-Promotion of CIMZIA (certolizumab pegol) for the Treatment of Adults with Moderate to Severe Crohn’s Disease (PRNewswire) – Jul 7, 2020 – “Ferring will take over marketing, sales promotion, and field medical affairs activities. UCB will continue to be responsible for all product-related activities, including revenue recognition….Ferring joins with UCB to promote CIMZIA prefilled syringe for Crohn’s disease in the U.S.”

 

Avsola (infliximab-axxq) / Amgen
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym (GaBI) – Jul 10, 2020 – “Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.”

 

Stelara (ustekinumab) / J&J
Joint Letter to CMS Advocates Against Adding Stelara to Self-Administered Drug List (The Rheumatologist) – Jul 6, 2020 – “Most recently, the ACR partnered with the Coalition of State Rheumatology Organizations and the Arthritis Foundation to send a letter to the Centers for Medicare & Medicaid Services requesting that it review the Medicare Administrative Contractors’ (MACs) decision to add this drug to the SAD list. Keeping Stelara off the list is important to ensure continued access for patients who can’t self-administer….Implementation is now planned for 45 days after the end of the public health emergency….ACR advocacy efforts will continue to prioritize protecting patient access to Stelara under Medicare Part B.”

 

Hulio (adalimumab biosimilar) / Mylan, Fujifilm Kyowa Kirin Biologics
Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio (adalimumab-fkjp) (PRNewswire) – Jul 9, 2020 – “Mylan…and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp)…for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations….In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023.”

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Weekly Top News – IBD – July 6, 2020

July 6, 2020

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima SC Including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis (Businesswire) – Jun 28, 2020 – “Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….’Remsima SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,’ said Professor Walter Reinisch….Celltrion has completed its application process for patent protection for the Remsima SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia.”

 

MORF-057 / Morphic Therap
Morphic Therapeutic Presents Positive Preclinical Data Supporting Development of MORF-057 in Inflammatory Bowel Disease at Digestive Disease Week 2020 (GlobeNewswire) – Jun 29, 2020 – “The data presented at DDW demonstrate that MORF-057 successfully targets the integrin α4β7 with high potency and selectivity. These studies recapitulate results from previous in vitro and in vivo models of increasing complexity and bolster the emerging profile of MORF-057 by demonstrating saturation of α4β7 in non-human primate receptor occupancy studies…IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020…”

 

spesolimab (BI 655130) / Boehringer Ingelheim
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis (clinicaltrials.gov) – Jul 1, 2020 – P2; N=79; Recruiting; Sponsor: Boehringer Ingelheim; N=535 –> 79

 

EUPHORIA: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (clinicaltrials.gov) – Jul 2, 2020 – P; N=504; Not yet recruiting; Sponsor: iThera Medical GmbH

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