Darvadstrocel

Medicine

EU EMA: by INN

Routes of
administrationInjectionATC code

L04AX08 (WHO)

Legal statusLegal status

UK: POM (Prescription only)^[1]
EU: Rx-only^[2]

IdentifiersDrugBank

DB16581

UNII

31W7R94KYT

KEGG

D11397

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]

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

^ ^a ^b "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 12 February 2020. Retrieved 27 February 2020.
^ ^a ^b ^c ^d ^e ^f "Alofisel EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2020.
^ ^a ^b ^c ^d ^e ^f ^g ^h 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.
^ NS Healthcare Staff Writer (28 September 2021). "Takeda's Alofisel approved in Japan to treat fistulas in patients with Crohn's disease". NS Healthcare.
^ "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.
^ ^a ^b Panés J, Bouma G, Ferrante M, Kucharzik T, Nachury M, de la Portilla de Juan F, et al. (November 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. PMC 9629463. PMID 35099555.