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Weekly Top News – IBD – May 13, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
A Phase 3 Study to Evaluate the Efficacy and Safety of the CT-P13 SC in Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 10, 2019 – P3; N=600; Not yet recruiting; Sponsor: Celltrion

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis by mid-2019 (Arena) – May 11, 2019 – Q1 2019 Results: Data from P3 trial for ulcerative colitis in 2021

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 10, 2019 – P3; N=372; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Entyvio (vedolizumab) / Takeda
A Phase 3 Study of Vedolizumab for Induction and Maintenance Therapy in Japanese Patients with Moderate to Severe Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; P3; “It additionally showed numerically greater clinical remission at Week 60 compared with PBO. VDZ is well-tolerated in induction and maintenance therapy in Japanese pts with moderate to severe CD with a safety profile consistent with non-Japanese studies.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Use is Not Associated with Increased Malignancy Incidence: Gemini Long-Term Safety Study Results and Post-Marketing Data (DDW 2019) – May 9, 2019 – Abstract #Su1835; Pres time: May 19, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – San Diego Convention Center; P3; “As observed numbers are small, individual malignancy data should not be over-interpreted, and the limitation that standardization does not correct for other potential confounders (e.g. smoking and body mass index) should be considered. Although limitations of post-marketing safety reports, including incomplete data and voluntary reporting of events, must be considered when interpreting post-marketing data, the number of malignancies with VDZ appeared low.”

 

Entyvio SC (vedolizumab SC) / Takeda
Effects of Subcutaneous Vedolizumab on Health-Related Quality of Life and Work Productivity in Patients with Ulcerative Colitis: Results from the Phase 3 Visible 1 Trial (DDW 2019) – May 9, 2019 – Abstract #Sa1878; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; “Similarly, signifi- cant improvements in work productivity measures were observed among patients treated with vedolizumab SC. Further investigation of the effects of vedolizumab SC on quality of life is needed to validate these findings.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and Safety of Mirikizumab (LY3074828) in a Phase 2 Study of Patients with Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #1003; Pres time: May 21, 2019; 10:00 AM – 10:15 AM; Location: Room: 20BCD – SDCC; P2; “Sustained efficacy and safety are currently being evaluated in a maintenance study. S-216AGA”

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Stelara (ustekinumab) / J&J
STELARA CD PMS: Post-Marketing Surveillance for Crohn’s Disease Participants Treated With Stelara (Ustekinumab) (clinicaltrials.gov) – May 8, 2019 – P; N=600; Recruiting; Sponsor: Janssen Korea, Ltd., Korea

 

Entyvio SC (vedolizumab SC) / Takeda
U.S. Food & Drug Administration accepts Takeda’s Biologics License Application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis (Takeda Press Release) – May 9, 2019 – “Takeda…announced that the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”

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