Darvadstrocel

Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy.[1] It contains mesenchymal stem cells from fat tissue of adult donors.[2]

Darvadstrocel
Clinical data
Trade namesAlofisel
Other namesCX-601
License data
Routes of
administration		Injection
ATC code
Legal status
Legal status
  • UK: POM (Prescription only)[1]
  • EU: Rx-only[2]
Identifiers
DrugBank
UNII
KEGG

It was approved for use in the European Union in March 2018.[2] The approval was spearheaded by data published in the ADMIRE-CD trial.[2][3]

It was approved for use in Japan by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2021.[4]

Medical use

Darvadstrocel has been approved by the European Union for the treatment of adults with complex Crohn's perianal fistulas after conventional or biological medications have not worked.[2]

Mechanism of action

Darvadstrocel works by reducing inflammation and facilitating the growth of tissue in the fistula tract.[2][3]

History

ADMIRE-CD

The ADMIRE-CD trial was a phase III trial that assessed the safety and efficacy of darvadstrocel vs. placebo in adults with complex perianal fistulas with Crohn's disease.[3][5] The study randomized a total of 212 patients.[3] 107 patients were given darvadstrocel and 105 patients were given placebo.[3]

After one year, the study found darvadstrocel to be effective in closing external fistula openings, compared to placebo.[3] Patients taking darvadstrocel had a combined remission of 56.3% and clinical remission of 59.2%.[3] The placebo controls had a combined remission of 38.6% and clinical remission of 41.6%.[3]

INSPECT

Published in 2022, the INSPECT study is a retrospective study that evaluated the long-term effectiveness and safety of darvadstrocel in patients with perianal fistulas in Crohn's disease that were treated in the ADMIRE-CD trial.[6] The study data showed that darvadstrocel or the maintenance treatment used can have long term clinical remission in patients.[6]

References
  1. "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 12 February 2020. Retrieved 27 February 2020.
  2. "Alofisel EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2020.
  3. Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, et al. (April 2018). "Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease". Gastroenterology. 154 (5): 1334–1342.e4. doi:10.1053/j.gastro.2017.12.020. PMID 29277560.
  4. NS Healthcare Staff Writer (28 September 2021). "Takeda's Alofisel approved in Japan to treat fistulas in patients with Crohn's disease". NS Healthcare.
  5. "Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD)". Clinicaltrials.gov. Archived from the original on 15 June 2012.
  6. Panés, Julian; Bouma, Gerd; Ferrante, Marc; Kucharzik, Torsten; Nachury, Maria; de la Portilla de Juan, Fernando; Reinisch, Walter; Selvaggi, Francesco; Tschmelitsch, Jörg; Brett, Neil R.; Ladouceur, Martin (31 January 2022). "INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial". Inflammatory Bowel Diseases. 28 (11): 1737–1745. doi:10.1093/ibd/izab361. ISSN 1536-4844. PMC 9629463. PMID 35099555.

Further reading


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