Darvadstrocel
Medicine
From Wikipedia, the free encyclopedia
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]
| Clinical data | |
|---|---|
| Trade names | Alofisel |
| Other names | CX-601 |
| Routes of administration | Injection |
| ATC code | |
| Legal status | |
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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Union in March 2018.[2] The approval was spearheaded by data published in the ADMIRE-CD trial.[2][3] Darvadstrocel was withdrawn from the EU market in December 2024.[4]
It was approved for use in Japan by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2021.[5] In January 2026, the marketing of Alofisel in Japan was discontinued.[6]
Medical use
Darvadstrocel was 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][7] 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.[8] The study data showed that darvadstrocel or the maintenance treatment used can have long term clinical remission in patients.[8]
ADMIRE-CD II
ADMIRE-CD II was an international, randomized double-blind placebo-controlled trial of the efficacy and safety of Alofisel (darvadstrocel) in treating complex perianal fistulas in 568 patients with Crohn's disease in whom immunosuppressive agents or biologics had failed.[9] The primary outcome (rate of combined remission at 24 weeks) was similar between treatments (48.8% darvadstrocel vs 46.3% placebo), as were all secondary outcomes. In December 2024, the European Medicines Agency withdrew the marketing authorization for Alofisel (darvadstrocel) upon request of Takeda Pharma.[10]
