Darvadstrocel

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

Darvadstrocel, sold under the brand name Alofisel, is a medication 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]

Hisotry

The ADMIRE-CD trial was a phase III trial that assessed the safety and efficacy of darvadstrocel vs. placebo in adults with Crohn's perianal fistulas.[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 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]

References

  1. 1 2 "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 12 February 2020. Retrieved 27 February 2020.
  2. 1 2 3 4 5 6 "Alofisel EPAR". European Medicines Agency (EMA). Retrieved 27 February 2020.
  3. 1 2 3 4 5 6 7 8 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.{{cite web}}: CS1 maint: url-status (link)

Further reading


This article is issued from Offline. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.