Clinical data | |
---|---|
Trade names | Alofisel |
Other names | CX-601 |
License data | |
Routes of administration | Injection |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
DrugBank | |
UNII | |
KEGG |
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]
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]
Darvadstrocel works by reducing inflammation and facilitating the growth of tissue in the fistula tract. [2] [3]
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]
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]