Darvadstrocel

Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn’s Perianal Fistulas

Retrieved on: 
Wednesday, October 18, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GI, Inflammation, TAK, CPF, Observational study, Asset, INSPIRE, Safety, European, Patient, Pharmaceutical industry, Medical device, Takeda, Darvadstrocel

Takeda (TSE:4502/NYSE: TAK) today announced that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel® (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on topline data.

Key Points: 
  • Takeda (TSE:4502/NYSE: TAK) today announced that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel® (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on topline data.
  • The safety profile for darvadstrocel was consistent with prior studies and there were no new safety signals identified.
  • “While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging," said Chinwe Ukomadu, head of the GI & Inflammation Therapeutic Area Unit at Takeda.
  • Any revisions to the consolidated forecast for the fiscal year ending March 31, 2024 (FY2023) will be announced during Takeda’s second quarter earnings call, scheduled for October 26, 2023.

2022 ISPE Facility of the Year Category Award Winners Announced

Retrieved on: 
Tuesday, April 26, 2022
People, Catalent, CRISPR Therapeutics, COVID-19, Czech Game of the Year Awards, Facility, Life, Transport, Project Mercury, Program, Patient, European Medicines Agency, Technology, Mercury, J&J, Supply, Therapy, ISPE, Pharma, Hercules, Achievement, VLF, Information, Environment, Solution, Medication, CRISPR, CEO, International, Darvadstrocel, Takeda, International Society, Safety, Industry, Association, Project, Creativity, BV, Vaccine, Innovation, Takeda Pharmaceutical Company, Face, Risk, COVID, Pharmaceutical industry, Fine chemical, Iovance Biotherapeutics

NORTH BETHESDA, Md., April 26, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) today announced the 2022 Facility of the Year Awards (FOYA) Category Winners at the 2022 ISPE Europe Annual Conference in Madrid, Spain.

Key Points: 
  • The Innovation Category was awarded to CRISPR Therapeutics for its facility in Framingham, Massachusetts, USA.
  • Janssen Biologics, BV won the Project Execution Category for its Vaccine Launch Facility (VLF) Expansion in Leiden, The Netherlands.
  • The 2022 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet, held in conjunction with the 2022 ISPE Annual Meeting & Expo , taking place 30 October2 November 2022.
  • The 2022 FOYA Overall Winner will be announced at the conference during the ISPE Membership Meeting and Awards Lunch on 1 November 2022.

Alofisel®▼ (darvadstrocel) Shows Clinical Remission Rate at Six-Months in the Real-World INSPIRE Study Interim Analysis Consistent with the Pivotal Clinical ADMIRE-CD Study1,2

Retrieved on: 
Friday, February 18, 2022
Oncology, Health, Stem Cells, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, United Kingdom, NASA Astronaut Group 13, Hydrogen peroxide, Patient, Colon, Risk, Infection, Pregnancy, Department, American Society of Colon and Rectal Surgeons, TAK, CD, Fistula, AT, Adult, Safety, Sodium chloride, Shamir Medical Center, INSPIRE, PP, Woman, Anesthetic, Needle, Streptomycin, Birth, Excipient, Diagnosis, Hypersensitivity, Phase 3, Methylene blue, Pharmaceutical industry, Vaccine, Takeda, European, Darvadstrocel, Alofisel, Takeda, ALOFISEL, TAKEDA

We are delighted to present the results of the first interim analysis from the real-world multicenter INSPIRE study.

Key Points: 
  • We are delighted to present the results of the first interim analysis from the real-world multicenter INSPIRE study.
  • Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Darvadstrocel is indicated.
  • Alofisel is not recommended during pregnancy and in women of childbearing potential who are not using contraception.
  • Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.